Drug Development Regulatory Specialist Jobs in Bengaluru

Senior Regulatory Affairs Specialist Location: Bangalore Company: AliveCor About AliveCor & The Opportunity AliveCor is a pioneer in **over-the-counter medical ECG devices**, dedicated to making heart health accessible. The company s **FDA-cleared medical-grade hardware and software** have enabled millions of heart health measurements, making a life-saving impact. We are seeking a **Senior Regulatory Affairs Specialist** to join our growing team. This is a critical role focused on **shaping regulatory strategy** for innovative mobile health technologies, managing product submissions, and ensuring compliance with international regulatory standards, including **ISO 13485 and FDA** Quality Systems. Role & Responsibilities As a Senior Regulatory Affairs Specialist, you will: Collaborate & Execute Regulatory Strategies: Work with product teams to **develop and execute global regulatory strategies** for registrations in the US, Europe, and other key regions. Manage Regulatory Submissions: Participate in the preparation and review of **global regulatory submissions**, including **510(k), de novo**, and other medical device filings. Support Government Interactions: Serve as the point of contact for regulatory agencies such as the **FDA, EU MDR**, and other international authorities, ensuring timely product approvals and licenses. Global Market Registrations: Drive product **registrations and renewals** for worldwide markets, supporting distributors with compliance documentation. Review & Approve Technical Documents: Assist in reviewing advertising, promotional materials, and technical documentation to ensure **compliance with applicable regulations**. ISO 13485 & FDA Compliance: Help implement and maintain an **ISO 13485 and FDA-compliant Quality Management System (QMS)**. Product Development Support: Collaborate with cross-functional teams (Engineering, Product, Quality) to support regulatory requirements during product development and design changes. Post-Market Compliance: Assist in post-market regulatory actions, including compliance with **reporting requirements and audits**. Requirements & Qualifications Experience & Education Experience: **4+ years in Regulatory Affairs within the medical device industry.** Education: Bachelor s degree in Science, Engineering, Math, or a medical field, or equivalent experience. Regulatory Experience with AI/ML: Experience in regulatory affairs for **software devices with AI/machine learning algorithms (SaMD)**. Core Regulatory Knowledge Global Regulatory Knowledge: Experience with **EU Medical Device Regulations (MDR)** and familiarity with regulatory processes in the US, EU, and Asia-Pacific regions. Regulatory Submissions: Experience preparing **510(k) submissions, pre-submissions, or de novo submissions** for medical devices. Skills Project Management: Ability to manage small projects with a focus on being organized, independent, and results-oriented. Analytical & Communication Skills: Excellent analytical, communication, and team collaboration skills, with a keen **attention to detail**. Preferred Qualifications Advanced Degree: Master s degree or regulatory affairs certifications such as **RAPS** (Regulatory Affairs Professionals Society). International Submissions: Experience in international submissions, especially in Asia-Pacific or LATAM regions. Perks & Benefits Working Model: Hybrid Working Model (Flexibility to work both remotely and in the office). Family Leave: Comprehensive Family Leave policies. Medical Benefits: Above-market family floater medical insurance, including coverage for parents/in-law parents. Office Perks: Complimentary lunch provided at the office and convenient metro connectivity. Qualification : Bachelors degree in Science, Engineering, Math, or a medical field, or equivalent experience

Medical Review Physician 1 Location: Bengaluru Employment Type: Full-Time About the Role We are seeking a detail-oriented and experienced Medical Review Physician to join our pharmacovigilance team in Bangalore. In this role, you will be responsible for the medical evaluation of individual case safety reports (ICSRs) across multiple data sources and therapeutic areas, ensuring compliance with global regulatory standards and internal quality benchmarks. Key Responsibilities Medical Review & Safety Assessment Perform medical review of both serious and non-serious ICSRs, with a focus on seriousness, expectedness, causality, and narrative quality. Review ICSRs originating from multiple sources: spontaneous reports, literature, regulatory authorities, solicited sources, and clinical trials. Evaluate and verify the selection of adverse events from source documents, assign appropriate MedDRA codes, assess product labelling, and review narratives for accuracy and completeness. Support triage activities and determine seriousness and relatedness across assigned products. Product & Process Expertise Maintain up-to-date knowledge of product portfolios and safety profiles across therapeutic areas, including Oncology, Respiratory, Immunology, Neuroscience, and Rare Diseases. Ensure timely completion of all medical review activities in line with regulatory timelines and service level agreements (SLAs). Contribute to process improvement initiatives, including implementation of quality control checks and feedback mechanisms. Collaboration & Training Provide expert medical guidance to case processors, data entry associates, and quality reviewers to address queries and discrepancies. Mentor and train team members in GVP concepts, case processing standards, and disease-specific medical knowledge. Collaborate with internal functional teams and client therapeutic groups to resolve case-related issues efficiently. Compliance & Quality Stay updated with ICH-GCP, GVP modules, 21 CFR, and other relevant regulatory guidelines. Deliver consistent, high-quality output while ensuring compliance with client-specific conventions and global safety standards. Take on additional tasks as assigned by the team lead/manager, adapting to shifting business priorities when necessary. Candidate Profile Education: MBBS or MD is required. Experience: 2 4 years of hands-on experience as a Medical Reviewer for ICSRs. Regulatory Knowledge: Strong understanding of ICH-GCP, Good Pharmacovigilance Practices (GVP), 21 CFR, and other international regulatory requirements. Technical Skills: Proficient in MS Office Suite (Outlook, Excel, Word, PowerPoint). Soft Skills: Excellent analytical, communication, and mentoring skills; ability to work independently and as part of a cross-functional team. Be part of a high-impact team contributing to global drug safety. Collaborate across a wide range of therapeutic areas and product portfolios. Develop and grow within a supportive, knowledge-driven work environment. Engage in continuous learning and professional development in a critical area of healthcare. Qualification : MBBS or MD is required

Lead/Associate Manager Case Processing 1 Location: Bengaluru Employment Type: Full-Time About the Role We are seeking a dynamic and experienced Lead/Associate Manager Case Processing to join our Pharmacovigilance team in Bengaluru. This role requires deep domain knowledge, leadership capability, and hands-on experience in handling Individual Case Safety Reports (ICSRs) across various sources. The ideal candidate will be responsible for managing day-to-day operations, ensuring compliance with global regulatory requirements, and mentoring a team of case processors. Key Responsibilities Operational Oversight Oversee and ensure the timely processing of ICSRs in accordance with SLA/KPI metrics. Allocate tasks effectively across the team to meet project deliverables and workload requirements. Proactively monitor team performance and work closely with team members to resolve operational or domain-related challenges. Risk & Issue Management Identify, escalate, and mitigate risks related to deliverables, compliance, or resourcing. Serve as a point of contact for internal stakeholders and clients regarding operational queries or escalations. Team Leadership & Performance Management Conduct regular performance evaluations, provide constructive feedback, and support career development of team members. Guide and mentor the team and Subject Matter Experts (SMEs) in ICSR processes, compliance standards, and MedDRA coding. Support functional capability development within the team and leadership pipeline. Training & Quality Assurance Conduct process and project-specific training as needed to ensure team competence and readiness. Ensure adherence to quality standards by contributing to quality system documentation, SOPs, and procedural updates. Provide feedback and suggestions to strengthen client/internal workflows and ensure continuous improvement. Process Improvement & Strategic Contribution Suggest and implement process enhancements to improve efficiency, accuracy, and compliance. Contribute to the development of scalable and sustainable pharmacovigilance processes. Collaborate cross-functionally to support strategic goals and business growth initiatives. Required Experience & Knowledge In-depth understanding of ICH-GCP, GVP modules, 21 CFR, and relevant global regulatory requirements. Proven expertise in managing high-volume ICSR workloads, including serious, non-serious, and potentially serious reports. Experience processing ICSRs from diverse sources: spontaneous, literature, solicited, regulatory authorities, and clinical trials. Exposure to therapeutic areas such as rare diseases and oncology is highly desirable. Experience in literature screening and review would be an added advantage. Proficient in MS Office applications (Excel, Word, Outlook, PowerPoint). Candidate Profile Education: Master s degree in Life Sciences, Pharmacy, or Medicine (or higher), aligned with project requirements. Experience: 10 12 years of relevant experience in pharmacovigilance, case processing, or related functions. Strong leadership skills with a proven ability to train, mentor, and manage cross-functional teams. Demonstrated ability to allocate resources, manage competing priorities, and maintain high-quality standards. Proactive, process-driven mindset with a commitment to continuous improvement and regulatory compliance. Work with a global leader in drug safety and pharmacovigilance services. Lead high-performing teams and contribute to the delivery of impactful healthcare solutions. Be part of a collaborative environment that values innovation, learning, and operational excellence. Apply now to lead meaningful work that impacts patient safety around the world. Qualification : Masters degree in Life Sciences, Pharmacy, or Medicine (or higher), aligned with project requirements

Assistant Risk Modelling Manager Location: Bengaluru Department: Risk & Modelling About OneSavings Bank (OSB) Group OneSavings Bank (OSB) Group is a specialist lending and retail savings group listed on the London Stock Exchange and a member of the FTSE 250. Headquartered in Chatham, Kent, OSB is regulated by the Prudential Regulation Authority and the Financial Conduct Authority. OSB focuses on niche lending markets offering high growth and strong risk-adjusted returns, including: Buy-to-Let and commercial mortgages Residential development finance Specialist residential lending and secured funding lines We operate under trusted brands such as Kent Reliance, CCFS, InterBay Commercial, Prestige Finance, and Heritable Development Finance. Retail savings are primarily sourced through Kent Reliance via branches, online, and postal channels. Our offshore delivery and support operations are handled by OSB India, with offices in Bengaluru and Hyderabad. About OSB India Pvt Ltd OSB India, a wholly owned subsidiary of OSB Group, plays a critical role in delivering operational and customer support services. Since 2004, OSB India has focused on service excellence, process efficiency, and continuous improvement for the group s UK operations. Role Overview As the Assistant Risk Modelling Manager, you will support capital and impairment reporting, provide deep data insights, and contribute to strategic projects. This role involves analysis, stakeholder collaboration, and ensuring regulatory and internal compliance. Key Responsibilities Lead and support monthly IFRS9 impairment and IRB RWA reporting with trend analysis and insights Provide analytics to support collections and help define operational priorities Drive and deliver strategic projects, managing timelines and stakeholders Assist with IFRS9 engine code changes, conduct impact assessments, and challenge trends Identify process and model weaknesses and develop mitigating solutions Produce clear, insightful commentary for credit and audit committees, including regulatory teams Ensure compliance with model execution and operational risk requirements Maintain adherence to Finance, Risk Management, and Data Governance Policies Build strong working relationships with UK stakeholders and capture clear requirements Complete all mandatory compliance training and attestations Experience Required Minimum 7+ years in a related role in retail or mortgage finance Extensive hands-on experience in SAS, SQL, and advanced Excel Proven ability to generate and present detailed analytical and reporting outputs Experience with impairment/capital modelling processes (preferred) Comfortable managing priorities, leading tasks, and collaborating with international teams Technical & Functional Skills Expert in SAS and SQL for data analysis and reporting Working knowledge of IFRS9 (impairment) or IRB (capital) frameworks Understanding of probability/statistics in a financial risk context (preferred) Core Competencies Strong analytical thinking and problem-solving skills Effective communication skills, both written and verbal Ability to deliver clear, actionable reports to senior stakeholders Self-motivated with a proven ability to learn new technical skills and tools This role is an exciting opportunity to work at the intersection of data, risk, and strategy within a dynamic and growing financial group. If you have a strong analytical mindset and are looking to influence real business decisions, we'd love to hear from you.

Investigator Payments Analyst Location: Bengaluru Job Overview: The Investigator Payments Analyst is responsible for supporting the delivery of all required start-up contracting activities for selected sponsors, studies, or multi-protocol programs. This includes pre-award activities and providing essential operational and financial contracting support. The role ensures compliance with sponsor requirements, regulatory guidelines, and project timelines. Essential Functions: Grant Estimates & Proposal Support: Develop simple investigator grant estimates and proposal text to support the proposal development process. Contracting Tools & Systems: Utilize and maintain contract and budget templates and contracting systems, tools, processes, and training materials for selected sponsors, ensuring alignment with the Scope of Work and Project Plan. Collaboration & Communication: Coordinate with sponsors, stakeholders, and RSU regions to ensure successful delivery of projects in compliance with sponsor requirements and the RSU Management Plan. Operational & Financial Support: Provide operational and financial contracting support to facilitate business development and efficient initiation and maintenance of clinical trials, ensuring compliance with regulatory requirements. Documentation Support: Assist in creating and reviewing scientific, technical, and administrative documentation to support business development and enable study initiation and maintenance. Contracting Intelligence: Contribute to the collection, interpretation, analysis, and dissemination of contracting intelligence for assigned studies and the company. Efficiency & Reporting: Ensure contracting efficiency and adherence to project timelines and financial goals, and report on performance metrics and out-of-scope activities. Compliance & Quality Standards: Ensure compliance with contract management and quality standards, providing administrative and operational support to investigators and managers as required. System & Database Management: Accurately complete and maintain internal systems (including CTMS), databases, tracking tools, timelines, and project plans. Qualifications: Education: Bachelor's degree required. Experience: At least 1 year of relevant experience, including demonstrable experience as a contract negotiator or equivalent combination of education, training, and experience. Skills & Knowledge: Negotiation & Communication: Strong negotiation and communication skills to facilitate contract discussions and maintain professional relationships with sponsors. Interpersonal Skills: Ability to work effectively in teams and with internal and external stakeholders. Technical Writing: Strong technical writing skills for creating and reviewing proposals and documentation. Clinical Trial Knowledge: Understanding of clinical trial environments and the drug development process. Regulatory Knowledge: Knowledge of GCP/ICH guidelines, applicable regulatory requirements, and SOPs. Organizational Skills: Excellent organizational and planning skills for managing contracting activities. Software Proficiency: Strong knowledge of Microsoft Office and other relevant software tools. Contract Management: Good understanding of clinical trial contract management, including pricing models, proposals, and budgets. Additional Skills: Ability to interpret pricing models, prepare proposals, bid grids, and budgets. Ability to work in a matrix team environment and build effective working relationships with sponsors, co-workers, and managers. Ability to exercise independent judgment when negotiating contracts and making decisions. This role offers an exciting opportunity for individuals who have a strong foundation in contract negotiation and management, along with an understanding of the clinical trial landscape. If you are a detail-oriented, proactive individual with a passion for working in the healthcare and clinical trial industries, we encourage you to apply. Qualification : Bachelor's degree required.

Job Description: Underground Cable Designer Transmission & Distribution Description: Experience in Design of Underground Power line projects using different software or relevant such as Civil 3D, MicroStation, ArcGIS. Role and Responsibilities: Prepare designs and drawings to be carried out in accordance with relevant codes of practice, standards, regulatory authorities, and clients' requirements. Coordinate with lower-level drafting personnel. Support their mentorship and technical development. Delegate and oversee workload to lower-level drafting personnel assigned to projects. Perform documented quality reviews of drawing packages adhering to the terms of the quality management system. Provide specialist knowledge input and keep up to date with the latest developments in particular fields. Innovate and identify optimal methods to perform design tasks. Be willing to make the necessary travels to carry out project requirements. Coordinate with project engineering and project management teams to ensure timely and quality deliverables. Perform QA/QC reviews of pulling calculations, alignments, layers, design standards, and construction design packages. Promote the interests of the company, for example through personal contacts, representation in professional groups, contributions at meetings and the publication of material where opportunities arise. Qualifications: Diploma in Electrical/Civil with 3-4 years of experience OR ITI in Electrical/Civil with 6-8 years of experience. Underground experience a plus. Transmission or distribution experience preferred. Proven verbal and written communication and IT (office packages) skills. Track record in finding solutions to complex problems within deadlines. Experience leading a team of engineers and designers. Managing multiple projects, deadlines, and deliverables in parallel. Communicating with multiple teams and stakeholders. Priority management and schedule planning. Knowledge of underground powerlines construction methods a plus. Knowledge regarding easements, right-of-way, and permitting considerations and impacts. Knowledge of creating plan & profile drawings using Civil-3D or MicroStation. Able to handle multiple projects simultaneously and to prioritize work. Knowledge of utility telecommunications, distributed energy resource integration, and advanced distribution technologies a plus. Strong analytical capability. Flexibility to work in different roles for different clients both locally and worldwide. Traveling will be a considerable advantage. Capable of devising new approaches to problems encountered. Qualification : Diploma in Electrical/Civil with 3-4 years of experience OR ITI in Electrical/Civil with 6-8 years of experience.

Key Responsibilities: Project Management & Execution: Lead and manage application projects related to Electronic Lab Notebooks (ELN) and data analytics. Prepare and track project plans, allocate work, track progress, and ensure end-to-end project delivery. Status & Performance Reporting: Regularly report project status, quality assurance activities, and performance to the customer. Present status reports and ensure the team is aligned with project goals. Documentation & Process Control: Maintain project documentation, including defect prevention checklists and project metrics. Collate status reports and other key documents for project tracking and stakeholder communication. Design & Architecture Reviews: Participate in design and architecture reviews, providing valuable inputs and suggestions. Identify any issues and drive them to resolution to ensure project continuity. Scope & Specification Management: Strategize and draft scoping documents and specifications to clearly communicate the project roadmap and ensure alignment with customer and stakeholder expectations. Cross-Functional Coordination: Collaborate with different teams within the life sciences group to ensure that project requirements are well-captured and reflected in project plans. Plan budgets and resources accordingly. Data Analytics & Dashboard Development: Develop and manage operational, scientific, and trending dashboards, ensuring data accuracy and actionable insights for the business and scientific teams. Validation & Qualification: Lead computer system validation (CSV) executions and the qualification of servers to ensure compliance with necessary standards and regulations. Key Skills: Electronic Lab Notebook (ELN): Expertise in ELN systems and their implementation, including data management, documentation, and integration into lab processes. Project Management: Proficiency in project management tools and methodologies to ensure smooth project execution, including planning, tracking, and resource allocation. Data Analytics & Dashboarding: Strong skills in creating and managing dashboards that provide operational, scientific, and trending data insights for decision-making. Computer System Validation (CSV): Experience in performing system validation activities, ensuring compliance with regulatory standards and guidelines. Documentation & Reporting: Ability to maintain accurate documentation, such as defect prevention checklists, metrics, and status reports. Skilled in presenting information clearly to stakeholders. Cross-Team Collaboration: Strong ability to coordinate with different teams, capture requirements, and plan resources and budgets for each build order, ensuring smooth execution. Quality Assurance: Ensuring that quality assurance activities are in place throughout the project lifecycle, maintaining high standards of work and compliance. Competencies: Business Acumen: Understanding of the business impact of project outcomes and making decisions that align with business goals and customer needs. Presentation & Communication Skills: Strong verbal and written communication skills, with the ability to present complex project details and data insights to stakeholders. Interpersonal Skills: Ability to build strong working relationships with cross-functional teams and stakeholders, ensuring effective collaboration and issue resolution. Team Management: Experience managing project teams, guiding them through day-to-day activities, and providing product perspective and solutions. Negotiation Skills: Ability to negotiate timelines, budgets, and resources with stakeholders and vendors to achieve the best outcomes for the project. Stakeholder Management: Skilled in managing expectations and requirements of internal and external stakeholders, ensuring alignment and satisfaction. Qualification : Bachelors / Masters (Electronic and Instrumentation / Computer Science / IT /Chemistry) with 8 - 10 years of experience.

About ICON: ICON is a world-leading healthcare intelligence and clinical research organization that accelerates the development of drugs and medical devices aimed at improving quality of life and saving lives. We offer outsourced services to pharmaceutical, biotechnology, medical device companies, and government/public health organizations. At the core of ICON s success is our people driven by passion, excellence, and a strong mission to succeed. Role Overview: The Senior ADaM Programmer will be responsible for creating and validating Safety and Efficacy analysis datasets, tables, listings, and figures in adherence with CDISC and client-specific standards. This position requires advanced skills in programming, effective time management, and proactive problem-solving to ensure high-quality deliverables in line with project timelines. Key Responsibilities: Programming & Data Analysis: Create and Validate ADaM Datasets for safety and efficacy domains, ensuring high quality and accuracy. Develop Safety and Efficacy Tables, Listings, and Figures to meet study specifications. Design and finalize study-specific macros and programming specifications/mock-ups. Troubleshoot and resolve programming issues in a timely and efficient manner. Adhere to programming specifications and study-specific requirements, ensuring complete documentation. Project Management & Collaboration: Plan, organize, and allocate tasks to ensure effective resource planning and adherence to project timelines. Proactively track workload and progress in accordance with KPIs and quality standards. Collaborate effectively with the biostatistics team, remote teams, senior programming staff, management, and sponsors to achieve study goals. Quality Control & Documentation: Maintain quality control and ensure the datasets are accurate and meet CDISC standards. Ensure compliance with industry regulations, standard operating procedures, and best practices in clinical programming. Required Qualifications: 6+ years of experience in ADaM programming and R. Strong proficiency in SAS programming, including SAS/Base, PROC SQL, SAS/Stat, SAS Macros, and SAS/Graph (both basic and advanced). Experience in creating ADaM datasets for safety and efficacy domains. Strong problem-solving skills, with attention to detail and ability to work independently and as part of a team. Verbal and written communication skills that ensure effective collaboration across teams and stakeholders. Benefits of Working at ICON: At ICON, we prioritize continuous learning and professional development. Our total reward package includes: Competitive base salary along with variable pay and recognition programs. Comprehensive benefits including health insurance, retirement planning, and more. Employee wellbeing initiatives that support you and your family throughout your career. A collaborative, inclusive work culture where diversity and career growth are encouraged. Diversity & Inclusion at ICON: ICON is an equal opportunity employer, committed to creating a workplace free from discrimination and harassment. We value diversity and encourage applicants from all backgrounds to apply. All qualified applicants will receive equal consideration for employment, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. How to Apply: If you're ready to contribute your skills to global healthcare solutions, apply now to join the ICON team and make a meaningful impact on patients lives around the world. This role presents an exciting opportunity for professionals looking to advance their programming career within a global leader in clinical research.

We are excited to announce an opportunity for a talented individual to join Ericsson as a Technology Specialist. This unique role offers the chance to provide technology leadership in sectors that are of strategic importance to our company. You will be instrumental in the development of innovative solutions, components, and products using cutting-edge technology. As a Technology Specialist, you will significantly contribute to the strategic planning to ensure the competitiveness of our product portfolio. This role requires a global nomination and appointment, with further details available . What you will do: - Drive technology leadership, becoming an in-house spokesperson and advisor to senior management. - Contribute to strategic planning and ensure a competitive product portfolio through technical investigations and task force contributions. - Align technology strategies with product and development goals, influencing Ericsson s research activities. - Judge and introduce new technology advances when they become mature and cost-efficient. - Provide in-depth technical solutions for complex problems and drive the innovation process. - Represent the company in relations with customers and educational institutions, and uphold our position as a technology leader. The skills you bring: Qualification: Bachelor's degree in Electrical / Wireless Communication Engineering. Minimum 8 years of experience in project management within a regulatory environment with specialized knowledge in wireless communication technologies, including Bluetooth, Wi-Fi, and GSM (4G and 5G). Strong knowledge of Wireless global regulatory requirements and experience with regulatory submissions. Excellent organizational, analytical, and problem-solving skills. Excellent written and verbal communication skills, including the ability to interact effectively with global functional teams. Outstanding teamwork and collaboration skills. Proficiency in Microsoft Office 365. Qualification : Bachelor's degree in Electrical / Wireless Communication Engineering.

Job Description Job title: Senior Regulatory Specialist Your role: The Senior Regulatory Specialist will develop and execute the regulatory strategy for new product development, design changes and field safety corrections for US, EU and RoW. Author 510k submissions, led pre-sub meetings, create EU MDR Technical Documentation, Health Canada license applications and lead interactions with regulators/competent authorities throughout review and approval process. Participate in strategic product development, design solutions starting from concept phase to product delivery phase and provide regulatory guidance throughout design and development. Act as a Regulatory Subject Matter Expert on various aspects and provide strategic guidance to the other RA Staff and project team. Able to manage special projects across spectrum of product lines. Monitor global regulatory landscapes and guide cross-functional team on implementation of regulation changes. Communicate new and coming changes, facilitate/assist with interpretation to guide product and business compliance with Regulatory requirements. Supports product defect assessments, issue impact assessments, health hazard evaluations, corrections and removals and CAPAs as a regulatory subject matter expert. Review labelling, marketing materials, and claims substantiation evidence to maintain compliance with global requirements. Identify areas for improvement for efficiency and compliance in internal processes, work instructions, and forms and apply technical expertise to process improvement efforts. Lead or participate on process improvement teams to affect changes at a local or cross business unit level. Opportunity for mentoring and coaching other regulatory team members and provide regulatory guidance. You're the right fit if: Minimum of 7-10 years of experience in the Regulatory Affairs medical device industry with regulatory submission experience 510(k) experience is preferred. Preferred candidate will have a master s degree in engineering or regulatory affairs or a related field with minimum of 7 years of experience. Will consider applicants Bachelors Degree with demonstrated experience working within Medical Device industry. Mastery in understanding, interpretation, and application of FDA 21 CFR 820 Quality System Regulations, EU MDR Regulation 2017/745, ISO 13485, and other relevant standards and regulations. Prior experience supporting/leading regulatory submissions such as 510(k), EU MDR Technical Documentations and global registrations Strong written, oral, and interpersonal skills required to work in a team environment as well as individual contributor with minimal supervision. Solution and detail oriented, well organized and self-motivated with ability to negotiate with regulators. May require up to 20% travel How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company s facilities. Field roles are most effectively done outside of the company s main facilities, generally at the customers or suppliers locations. Indicate if this role is an office/field/onsite role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. Qualification : Preferred candidate will have a masters degree in engineering or regulatory affairs or a related field with minimum of 7 years of experience.

Job Description Job title: IT Platform Analyst Your role: Translates business requirements into user stories and Functional Requirement Specifications in accordance with approved IT Architecture. Provides feedback on the efficiency and effectiveness of the business processes. Supports DevSecOps Manager, Project Manager & Domain Lead during the pre LPC phase in evaluating the solution feasibility, solution design and high-level estimation. Supports the DevSecOps Manager, Project Manager in validating estimations provided by partners, and timely provision of technical environments. Develops and provides required user training for the implemented application. Collaborate with Business, IT Business Partners, Architects and Tech Leads to elaborate on the requirements. Understands how the IT solution supports the Business Process E2E. Has process and IT landscape expertise on Sector level, BG, Markets or Functions. Responsible to promote out of the box functionality to the BPE and Business community. Develop user stories/ wireframes (both functional and system operational requirements), maintain product backlog and work with client on elaboration and ambiguity resolution. Prior to UAT validates that solution meets business requirements. Responsible to validate test plan and functional test cases and sign off acceptance of the product Coaches the Business Analyst and functional consultants including partners. Promptly escalate issues, which affect product delivery and quality that are beyond scope of influence. Responsible for Software Quality, Compliance & Regulatory aspects of the solution. Ensure seamless business operations support (third line support) when needed. Responsible for designing use cases and acceptance criteria. Drive business process harmonization using industry best practices. Should be able to look beyond the current scope of work and be able to propose newer IT business propositions to stake holders and also recommend innovations to platform providers. Responsible to drive UAT and testing of functionality. Responsible to support DevSecOps Manager on Regulatory and compliance aspects of the project. Responsible for development and maintenance of WiKi and KM artifacts. You're the right fit if: 8-15 years in SAP SD/CS and GATP experience of at-least 8+ years At-least 2-4 full end to end implementation experience mandatory Exposure to all domains in SAP MM, SD, CS, LE and APO Procurement, Warehouse Management, Order Management, 3PL logistics, ATP and GATP, MRP, Variant configuration, 3rd Party Delivery process, STO, MIC, Quality Plan & Materials, Vendor. Integration between MM/SD//PP/FI/WM/PS, EDI and IDOC Concepts on S4 Hana, IoT, Cloud solutions Experience in requirement gathering, fit gap, translating business requirement into high level solutions and detailed functional design. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company s facilities. Field roles are most effectively done outside of the company s main facilities, generally at the customers or suppliers locations. Indicate if this role is an office/field/onsite role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.

Job Purpose and Impact The Controls Testing Specialist will lead and execute testing engagements of IT controls within different technology control domains. In this role, you will consult with business relationship managers, project managers and other key stakeholders to ensure a coordinated approach to monitoring effectiveness of control design and implementation across the organization. Key Accountabilities Participate in the development and execution of assurance processes to ensure appropriate process, procedures and controls are adequately designed, implemented or remediated to meet compliance expectations, efficiency, sustainability goals and business objectives. Test the design and operational effectiveness of existing controls and recommend improvements to align with evolving regulatory and business needs. Write reports with identified findings and provide recommendations. Perform testing engagements including closure within the planned timelines. Consult, validate and monitor the implementation of remediation activities as result of testing findings and other identifications of non-compliance. Collaborate with risk analysts across all areas of the business on common risks to achieve optimization and coordination of remediation activities. Maintain and manage assurance documentation and records. Independently solve moderately complex issues with minimal supervision, while escalating more complex issues to appropriate staff. Qualifications MINIMUM QUALIFICATION Bachelor s degree in IT or CA with IT audit experience. Professional certifications such as CISA, CRISC will be a plus. Strong knowledge of regulatory requirements and compliance standards, such as COSO - SOX, SWIFT, NIST, ISO, COBIT and CIS Knowledge and understanding of Technical Security controls at Network, Server and Application layers Excellent report writing and presentation skills PREFERRED PRIOR EXPERIENCES 5+ years of experience in Audits or Controls Testing or Risk assessment services of IT infrastructure, Applications, IT processes, Business Continuity and Governance. Experience in the implementation of risk remediation activities internally and for external stakeholders Hands-on experience in Test of design controls and Test of operating effectiveness review of IT operational controls. Ability to ensure compliance with risk and security or regulatory policies, standards, procedures and guidelines. Ability to define issues, collect data, establish facts and draw valid conclusions. Respond to and assist with consultation for low complexity risk and security matters. Qualification : Bachelors degree in IT or CA with IT audit experience. Professional certifications such as CISA, CRISC will be a plus.

Role Summary As a Senior Consultant and Subject Matter Expert (SME) specialising in the Banking and Financial Services (BFS) Industry in India, we are seeking a distinguished professional with over 15 years of experience to join our team. The successful candidate will be a seasoned expert in BFS operations, possessing extensive knowledge of banking and financial services, combined with a profound understanding of the regulatory landscape in the Indian market. This role is pivotal in steering our organization toward strategic development in the realm of Digital Technologies BFS services. Key Responsibilities Act as a senior SME, providing expert guidance on Banking and Financial Services operations, products, and services within the Indian market. Collaborate seamlessly with cross-functional teams to optimise and enhance business processes. Provide strategic guidance to the team on IT and Digital Technologies Banking and Financial services. Conduct thorough assessments to identify and mitigate risks associated with BFS operations. Conduct in-depth analysis of business operations, processes, and challenges, identifying opportunities for improvement and innovation through interviews, workshops, and data analysis. Engage with senior leadership to offer strategic insights and recommendations. Contribute actively to the development and execution of business plans within the BFS domain. Foster and maintain effective relationships with regulatory bodies, industry associations, and other external stakeholders. Experience working in Banking Enterprise preferably in Retail Banking business. Possess a comprehensive understanding of the BFS sector in India. Exposure to IT services and product development within the BFS landscape. Showcase proven leadership skills with the ability to influence and guide cross-functional teams. Lead and mentor junior Business Analysts, fostering a collaborative and high-performing team environment. Exceptional communication and interpersonal skills, influencing stakeholders at all levels and building strong relationships. Proficiency in relevant tools and technologies, including Visio, UML, MS Office Suite, data analysis tools, and project management software. Excellent analytical and problem-solving skills with the ability to translate business needs into technical specifications. Proven ability to work independently and manage multiple projects concurrently. Familiarity with RBI regulations, SEBI guidelines, and other relevant laws governing the Indian financial services industry (AML, KYC, BSA, SOX, PCI DSS, CFPB, GDPR, SEC, FATF, Basel III) Qualifications Education: Minimum Bachelor's degree in Finance, Business, Law, PGDBF or a related field. Advanced degrees like MBA Finance, MFC, MFM, CFA or relevant certifications are preferred. Skills Desired Preferably having experience in Global BFS domain. Leverage an established network within the Indian BFS sector, including regulatory bodies, industry associations, and peer organizations. Ability to adapt seamlessly to a rapidly changing regulatory environment and evolving industry trends. Demonstrate a track record of thinking creatively and proposing innovative solutions to complex problems. Competencies Desired Technical / Functional: Relevant certifications in the BFS domain, risk management, compliance, or related fields (e.g. CRMA, CISA, CAMS, PRM, CFSA) will be considered a valuable advantage. Relevant BA certifications (e.g., CSPO, CBAP, PMI-PBA) would be an added advantage. Qualification : Minimum Bachelor's degree in Finance, Business, Law, PGDBF or a related field. Advanced degrees like MBA Finance, MFC, MFM, CFA or relevant certifications are preferred.

Job Purpose: The Director Process Management will be accountable for overseeing and optimizing assigned end-to-end business processes within Global Clinical Operations (GCO) to drive efficiency, compliance, standardization, and continuous improvement across the organization. They will lead and work collaboratively with cross-functional teams to identify areas for process improvement & innovation, implement best practices, control process health & compliance, and ensure processes align with GSK s strategic goals. Key Responsibilities: The responsibilities listed below outline the scope of the position. The application of these tasks may vary, based upon evolving business needs. As the Global Process Owner for assigned processes lead the design, maintenance, and continuous improvement of these end-to-end processes. Ensure these processes comply with regulatory requirements, are aligned with GCO s strategies, consider innovative approaches being developed in the industry, drive efficiency, and are well defined. Ensure that written standards are developed and maintained as needed to support the process and that written standards can be clearly understood by end-users. Provide necessary information and training to help users understand and implement these processes effectively. Define and implement process oversight strategy with key performance indicators, in-process controls, management monitoring and end-user feedback. Establish benchmarks and conduct periodic review of performance metrics to ensure effectiveness, efficiency, and compliance. Report process health and compliance to the relevant stakeholders proactively and take appropriate measures where deficiencies are identified. Influence and engage with the organization by building a strong network with stakeholders, partners, and subject matter experts to understand their drivers and needs along with broader organizational goals. Use these insights to craft alignment, drive meaningful change and improve end-user experience. Define and manage process change roadmaps, aligning priorities with system updates and innovations to address evolving business needs, manage risks or interdependencies, and implement improvements at scale. Lead strategy, planning, execution, and implementation of process change projects, ensuring improvements are achieved through a combination of process-people-system solutions. Partner with subject matter experts and support roles to deliver a comprehensive solution package that includes the end-to-end process itself, written standards, training, communication, change management, implementation, and monitoring plans. Maintain current knowledge of global regulations and guidance, global regulatory expectations, regulation intelligence and industry standards pertaining to the assigned processes. Proactively assess impact of any new regulations on assigned process and ensure ongoing compliance. Proactively educate themselves in evolutions and innovations across the industry and evaluate how they could positively benefit the effectiveness, efficiency or compliance of the process. Develop and align proposals with the appropriate stakeholders to drive process innovation that is aligned with GCO s strategic priorities and stakeholder needs. Maintain personal readiness to respond to internal audits and regulatory inspections, be the point of contact and interact with inspectors, and provide expert advice to respond to audit observations. Represent GSK in external forums to influence the external ecosystem in shaping industry-leading practices and development of innovative methodologies Basic Qualifications Bachelor s degree in Scientific discipline. Extensive experience in Pharmaceutical or Biotech industry working in Clinical Operations, Operational Excellence, or a related field. Excellent understanding of clinical operations processes, and ICH/GCP and global regulatory guidelines for drug development and approval processes with specific expertise in informed consent, clinical trial supplies and distribution of clinical safety documents. Experience leading major projects to completion and driving cross-functional improvements. Strong strategic and critical thinking, problem solving, influencing and decision-making capabilities. Forward-thinking and visionary mindset to modernize approach to clinical processes and leverage technology. Demonstrated matrix team leadership to deliver results. Demonstrated cross-functional collaborator with experience in building networks of partners and stakeholders, and broadly engaging with expert communities. Effective communication skills with ability to communicate and influence. Preferred Qualification Advanced degree in Scientific discipline Qualification : Bachelors degree in Scientific discipline.

Site Name: Bengaluru Luxor North Tower Posted Date: Dec 16 2024 GSK is a global biopharma company with a special purpose to unite science, technology and talent to get ahead of disease together so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world over 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves feeling welcome, valued and included. Where they can keep growing and look after their wellbeing.So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Key Responsibilities As a Director , R&D Tech Governance Risk and Compliance , you will be responsible for providing management and day to day support to the Senior Director for Governance, Risk & Compliance activities across the assigned business unit ensuring that Tech risks & controls from project inception to support within their business unit are identified, prioritized, effectively managed, and monitored.This role should work within the business unit to ensure Tech follows the required internal and external compliance standards and delivers a reduction in the overall risk profile for our customers. The primary responsibility of this position will be supporting R&D Tech. Additionally, this role will serve as the Bangalore site lead and play an active role in managing site-specific activities and HR related processes for GRC staff based in Bangalore GCC office. This role will provide YOU the opportunity to lead key activities to progress YOUR career. The role encompasses the following responsibilities: Risk and Compliance Consultancy on strategic programs Facilitate and approve Risk & Compliance Assessments Management and monitoring of CAPAs, Risks, Exceptions, ABAC, and Findings Contribute to the facilitation of functional Risk Management and Compliance Boards (RMCB) Partner with Business Quality Assurance teams for GxP compliance Support Internal / External audits including Audit Readiness activities Provide GRC support and oversight during application development and maintenance Software Change Management Oversight for GxP regulated applications Authorize systems releases Lead and motivate team of GRC manager and specialists Risk Management Contribute to identification and initiation of Risk mitigation projects to address significant risks impacting a Business unit, using Risk and Compliance assessments Facilitate risk identification and risk discussions within the business unit, both operational risk, product/project and strategic risk Assist Tech Business Unit management to make risk informed decisions through a comprehensive Risk Dashboard Raise and approve (where necessary) Policy Exceptions and significant Risks through the GSK integrated risk management tool (i.e., Archer). Input into, review and enforce compliance within Tech Policies and Standards as required within Business Unit Ensure emerging risks are identified and escalated appropriately and in a timely manner Support Product owners in the management of their project risks, ensuring risk identification process is embedded and operational Ensure awareness of security incident response process and report suspected security breach Partner with other GRC and Security staff to deliver a continuous training and education program to ensure ongoing awareness on new and updated Policies and Standards within their Business Unit. Governance & Compliance: Contribute to maintenance of the Business Unit delivery and operational frameworks (Activities, deliverables, roles and responsibilities) and ensure alignment to DTMS Monitor deliverable quality, ensure quality standards are being met for products/ projects, programs or operations within their remit, following a risk based approach, according to DTMS, risk and compliance assessments, and local SOPs. Contribute to providing Project Quality assurance oversight depending on the specific project risk profile, including specific assurance reviews as requested by stakeholders Ensure Business Unit activities align with Regulatory requirements and liaise with Business Quality Groups to contribute to the overall GxP validation status of the business facing application systems or services Contribute to ensuring Business Unit is keeping up with regulatory and legal requirements through a pro-active knowledge management program Quality assurance over the system change control within the Business Unit Supporting Product teams to maximize their velocity by right sizing their governance approach Audit Support Contribute to ensuring Business Unit is ready to host external inspections from regulatory bodies (i.e., FDA, EMEA, tax authorities) as well as external and internal auditors. Support management of overall Business Unit inspection readiness activities and CAPAs in liaison with the business Report status on CAPA s to Business Unit RMCB Information Policy Formation Work with the GRC GxP lead/Controls owners and DTMS team to review and approve the policy, standards, procedures, guidance and training for compliance with relevant legislation and GSK Requirements. Support reviews of the information systems for compliance with legislation and specifies any required changes within their Business Unit Support the GRC Director to implement policies, standards and procedures with aligned Tech Business GRC Consulting Support various GRC planned or remediation activities consulting with BU Tech staff to deliver Support implementation of relevant Management monitoring prog...

Basic Qualification: 16 - 21 Years of professional experience. Experience in Regulatory life Cycle till Phase 4. Location - Bangalore. Would you like to drive change and transformation efforts that enable successful regulatory outcomes for GSK? If so, this Manager, Regulatory Asset Oversight role could be an ideal opportunity to explore. As Manager, Regulatory Asset Oversight, you will manage multiple projects and teams simultaneously and will provide assessments (metrics, data) and conclusions/action plans within and across departments. You ll identify risks associated with submission data and information packages, and lead in the creation, maintenance and continuous improvement of Regulatory processes, policies and systems. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following In close collaboration with the GRL and RMT, develop and maintain a holistic view of the global regulatory integrated plan at the asset level for operationalizing the Global Regulatory Strategy and supporting the GRL in ensuring appropriate resource is engaged to deliver to the plan, Drive the execution of the agreed plans to ensure team is on-track to deliver per the Global Regulatory Strategy (GRS), performing scenario planning, impact analyses, critical path analyses and facilitate risk mitigation in response to any issues/risks that arise. Leverage expertise to assist RMTs and GRLs with submission delivery strategies that align with R&D objectives, e.g. Hyper-Acceleration, Acceleration in regions. Implement a structured approach with assigned RMTs to ensure that the submission delivery strategy is aligned with the Global Submission Strategy (GSS) throughout the late-stage Development lifecycle. Proactively partner as a Single Point of Contact with RMT, Submission Coordination, and Publishing colleagues to identify and remove barriers that will prevent a successful outcome on defined filing strategies. Drive the RMT Meeting and other Cross-Functional, Regulatory-Owned Engagements for success ensuring logistics, agenda topics and meeting materials are available and organized for the use of the team. Proactively identifies upcoming activities or milestones which might impact regulatory deliverables and escalates of issues and blockers to the Director, Regulatory Asset Oversight, and leadership. Promote and drive the use of integrated Regulatory technologies to provide real-time, accurate submission status information (visuals and reports) for RMTs to highlight compliance from central dispatches through to registrations across markets. Maintains meaningful metrics and KPIs to assess individual and team performance which are aligned across the Regulatory Asset Oversight function. Support the GRL in the preparation of governance reviews leveraging data from RIM systems and ensuring accuracy, completeness, and fit for purpose. Facilitate discussions with LOCs and RMTs as needed to ensure aligned submission delivery strategy and efficient lifecycle filing strategies from lead markets through to regional expansion. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor s Degree Extensive knowledge of drug development and manufacturing and supply processes. Broad and deep knowledge of worldwide regulatory requirements. Successfully managed multiple projects Preferred Qualifications: If you have the following characteristics, it would be a plus: Degree in Chemistry, pharmacy or closely related science Demonstrated professional growth in global regulatory affairs including communication of evolving/emerging trends and policies. Broad knowledge base across regulatory functions. Experience in influencing and negotiating with GSK personnel as well as external partners in a variety of settings. Line management experience Why GSK? Our values and expectationsare at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Agile and distributed decision-making using evidence and applying judgement to balance pace, rigor and risk. Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose to unite science, technology and talent to get ahead of disease together so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it s also about making GSK a place where people can thrive. We wan...

Job Title: Statistical Programming Associate Director Career Level - E Introduction to role The Statistical Programming Associate Director is accountable for the quality, timely, and efficient delivery of project programming work and good information management. This position requires profound programming experience and excellent industry knowledge to independently lead the implementation of programming activities as well as lead other programmers. It is a leadership role that can have a project or technical focus. It will provide subject matter expertise within the Programming discipline. As an expert within their own field, you will act as a specialist within cross-functional teams to deliver continuous improvement. Accountabilities Leads and directs the full scope of project delivery and/or leads a technical project within the TA/Drug Project/study/function Leads implementation of statistical programming aspects of the protocol or clinical development program Responsible for the high quality of all project deliverables, holding partners and providers accountable for the quality of their deliverables and/or technical subject matter expert for aspect(s) of the TA, Project, or function Leads or contributes to cross-functional administrative or process improvement initiative(s) Drives the development of best practices to improve quality, efficiency, and/or effectiveness within the function Drives standards development and implementation Manages and escalates risk in complicated or novel situations within their study and/or projects Provides Programming expertise to the team Provides tactical input and/or drives ideas and improvements Contributes to the function by supporting recruiting and/or providing training and mentorship Identifies opportunities to improve methodology and provides practical solutions for problems Manages activities of our external partners (i.e., Contract Research Organisations) Influences stakeholders by providing subject matter expertise on programming-related items Ensures compliance with standards and automation usage Employs all project management practices in managing drug or technical projects Provides input to capacity management for all projects in scope Maintains expertise in the latest industry and regulatory requirements to stay current Essential Skills/Experience Degree in Mathematics (i.e., Applied Math, Engineering, etc), Statistics, Computer Science, Life Science or equivalent Proven programming expertise Thorough knowledge of the clinical development process Thorough knowledge of industry standards and ability to implement them Ability to apply programming expertise to problem-solving and troubleshooting for teams Current knowledge of technical and regulatory requirements relevant for the role Ability to proactively manage concurrent activities within a project Proficient ability to influence relevant stakeholders on programming-related items Ability to manage risk in complicated or novel situations Project Mindset AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. Qualification : Degree in Mathematics (i.e., Applied Math, Engineering, etc), Statistics, Computer Science, Life Science or equivalent

Quality Manager Location: Bangalore Department: Operations About the Role IRP Systems, at the forefront of **high-performance e-powertrain systems**, is seeking an experienced **Quality Manager** to oversee all quality assurance and control activities in its automotive manufacturing environment. You will be instrumental in ensuring products meet **customer and regulatory standards** while continuously driving improvements in processes, reliability, and customer satisfaction. Key Responsibilities Quality Management System (QMS): Develop, implement, and maintain the QMS according to **IATF 16949**, **ISO 9001**, and customer-specific requirements. Quality Team Leadership: Lead and manage a team of quality engineers, inspectors, and technicians, ensuring adherence to quality standards and consistency. APQP & Core Tools: Manage **Advanced Product Quality Planning (APQP)**, **PPAP**, and **FMEA** activities to integrate quality into every stage of the product lifecycle. Quality Metrics Monitoring: Track and analyze key quality metrics (e.g., **scrap rate, PPM, customer complaints, warranty data**). Drive corrective actions for continuous improvement. Audits: Lead internal and external audits (**IATF, ISO, customer, and supplier audits**), ensuring full compliance with all quality standards. Customer Interface: Serve as the primary point of contact for customers regarding **quality issues** and performance reviews. Supplier Quality Management: Oversee **supplier qualification, audits, and corrective actions** to ensure quality consistency throughout the supply chain. Root Cause Analysis & CAPA: Facilitate **root cause analysis** and lead the implementation of **Corrective and Preventive Actions (CAPA)** to resolve issues and prevent recurrence. Continuous Improvement: Promote and lead a culture of continuous improvement using methodologies like **Lean, Six Sigma**, and problem-solving tools (**8D, 5 Whys, PDCA**). Compliance: Ensure compliance with all relevant safety, environmental, and regulatory standards applicable to the automotive industry. Skills and Qualifications Experience & Education Education: Bachelor s degree in Electronics Engineering or related fields. Experience: Minimum of **8 years in a Quality leadership role** within the automotive industry, and at least **10 years of experience in electronics and mechanical manufacturing**. Certifications & Standards Expertise Certifications: **Six Sigma Green/Black Belt certification is required.** Standards Expertise: Extensive knowledge of automotive quality standards (especially **IATF 16949**) and familiarity with **ISO 26262 (Functional Safety)**. Technical & Analytical Skills Quality Tools Proficiency: Expertise in using core quality tools such as **8D, APQP, FMEA, SPC, and MSA**. Manufacturing Knowledge: Familiarity with advanced manufacturing processes and technologies relevant to the automotive industry. Analytical Skills: Strong problem-solving and analytical skills to effectively address and resolve customer quality issues. Impactful Work: Contribute to the development of **high-performance e-powertrain systems**. Career Growth: Be part of a dynamic and rapidly growing company with opportunities for professional development. Competitive Benefits: Competitive compensation, flexible working options, and health coverage. Qualification : Bachelors degree in Electronics Engineering or related fields

Position: Finance Specialist Job Type: Full-Time Location: Bangalore Department: Finance About BlueOptima: BlueOptima s vision is to become the global reference for optimizing the performance of software engineers across all industries. We provide industry-leading objective metrics in software development, empowering large organizations to deliver better software, faster, and at a lower cost using groundbreaking technology. With headquarters in London and offices in Mexico, India, and the USA, we ve consistently doubled our headcount and revenue year over year, with no external investment. Our diverse team of 115+ employees comes from over 34 nationalities and speaks more than 25 languages. We promote an open-minded environment and encourage every individual to create their own success story within this high-performance atmosphere. Job Description: We are looking for a Finance Specialist to join our Finance team in Bangalore. Reporting to the Finance Manager, this role will be a key part of the day-to-day financial operations and accounting of the business. You ll be working closely with the finance team and other departments to ensure the timely and accurate delivery of financial data, as well as helping to evolve our financial processes. Key Responsibilities: Finance Operations Management: Oversee the day-to-day operations of the finance team, including managing Accounts Payable (AP), Accounts Receivable (AR), and payroll across all locations. Accounts Payable & Receivable: Ensure timely and accurate payments of dues and collections from customers. Handle vendor invoicing, reconciliations, and communications. Payroll Management: Take ownership of the payroll process, ensuring timely and accurate processing across all locations. Be the go-to person for payroll-related queries from employees. Cross-Functional Collaboration: Work closely with finance consultants and internal teams across various locations on accounting and compliance topics. Month-End & Year-End Closures: Assist with month-end and year-end closures, ensuring books are closed accurately and on time. Audit Support: Provide assistance during local and group audits, ensuring that all financial documents are accurate and comply with regulations. General Ledger (GL) & Reconciliation: Review and maintain GL accounting, perform balance sheet reconciliations, and conduct variance analysis for cost and revenue items. Process Improvements: Review existing financial processes and provide suggestions for improvements to increase efficiency and effectiveness. Global Finance Projects: Gain exposure to global finance projects, working across functions to enhance learning and development opportunities. Qualifications: Essential Requirements: Education: Bachelor's/Master s in Accounting & Finance (e.g., BCom, MCom, MBA). CA Inter cleared is a plus. Experience: Minimum 3-4 years of experience handling AP, AR, and payroll processes. Accounting Fundamentals: Solid understanding of basic accounting principles and financial processes. Taxation Knowledge: Understanding of taxation concepts, such as GST, TDS, and sales tax/VAT. Technical Skills: Proficient in spreadsheet tools (e.g., Excel) and presentation software (e.g., PowerPoint). Cloud-Based Accounting Tools: Experience with cloud-based accounting tools such as Zoho, Xero, QuickBooks, etc. Multi-Region, Multi-Currency Setup: Experience working in a multi-region, multi-currency environment is a plus. Taxation Experience: Experience reviewing and handling sales tax/VAT for the US/UK is an added advantage. At BlueOptima, you ll have the opportunity to make a significant impact on our financial operations while working in a dynamic and fast-growing global company. You ll gain exposure to cross-functional collaboration, global finance projects, and the chance to continuously develop your skills in a high-performance environment. Qualification : Bachelor's/Masters in Accounting & Finance (e.g., BCom, MCom, MBA)

Director Data Management (Data Migration & Automation) Location: Bangalore, India About MaxVal Founded in 2004, MaxVal is a pioneer in IP services focused on efficiency, cost-effectiveness, and continuous improvement driven by metrics-based processes. Our technology-driven IP solutions serve over 600 clients globally. With a talented team of 725+ IP and tech experts, MaxVal continuously innovates to deliver exceptional customer and employee success. Job Summary MaxVal is looking for an experienced and visionary Director of Data Migration and Automation to lead our data migration initiatives. You will oversee migrating data from various IP solutions to our software platform, ensuring accuracy, integrity, and efficiency through automation. This leadership role requires strategic thinking, strong domain expertise in Intellectual Property, and the ability to inspire and guide a team of specialists. Key Responsibilities Team Leadership & Management Lead, mentor, and empower a team of Data Migration specialists, ensuring resources and guidance for successful project delivery. Cultivate a collaborative, client-centric culture within the team. Data Mapping & Transformation Design comprehensive data mapping and transformation plans aligning external IP data with MaxVal s platform. Maintain data integrity and consistency throughout migration. Competitor Data Analysis Analyze competitor IP data structures and models to inform effective migration strategies. Automation System Development Architect and develop automation solutions to streamline migration workflows, including data mapping and transformation. Create processes and scripts to automate repetitive tasks and enhance efficiency. IP Domain Expertise Utilize deep knowledge of IP data types (patents, trademarks, copyrights, legal entities). Collaborate with legal experts to ensure precise migration of IP information. Technical Integration & Customization Partner with technical teams to embed automation into migration workflows. Customize automation tools to accommodate unique IP and legacy system requirements. Quality Assurance & Testing Define QA protocols specific to IP data migration. Conduct thorough testing to validate data accuracy and completeness. Stakeholder Engagement Interface with clients to understand migration needs and challenges. Offer expert recommendations to achieve successful migration aligned with client goals. Continuous Learning & Innovation Stay abreast of industry trends, best practices, and emerging technologies in data migration and automation. Drive continuous improvements in automation and migration efficiency. Cross-Functional Collaboration Work closely with product, engineering, and client-facing teams to ensure migration success and contribute to product enhancements. Documentation & Knowledge Sharing Maintain detailed documentation of migration processes and automation workflows. Lead workshops and training to disseminate best practices internally and to clients. Requirements Experience: 15+ years leading data migration projects in software implementations. 10+ years in leadership roles managing and mentoring teams. Expertise: Strong knowledge of data migration methodologies, tools, and best practices. Familiarity with automation tools, database management, and data integration platforms. Deep understanding of the Intellectual Property domain is highly preferred. Skills: Strategic leadership with excellent communication and stakeholder management skills. Ability to drive innovation and build scalable automation solutions.