FDA Jobs in Bengaluru

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

Job Title: R&D Scientist Validation, Fast Trak Process Design & Validation Services Location: Bengaluru, India About the Role: We are looking for an R&D Scientist Validation to support the design, execution, and validation of new or improved services as part of our R&D strategic plan. This role will focus on validation services across the bioprocessing portfolio and involves working from early concept development through testing and final implementation. The position also contributes to lab and facility setup and ensures all necessary documentation is in place for successful service launches. Key Responsibilities: Provide technical support on innovation and development projects, collaborating with R&D project managers and cross-functional teams to ensure timely and efficient delivery. Assist in defining technical requirements based on customer and market needs to guide new service/product development. Help plan, assess risks, execute, and document technical studies at different stages of project development. Design and execute verification and validation studies to confirm alignment of service/product outputs with technical and marketing specifications. Support laboratory operations and ensure adherence to Environment, Health & Safety (EHS) standards and regulatory compliance. Qualifications: Bachelor s, Master s, or Ph.D. in Molecular Biology, Biochemistry, Bioengineering, or a related scientific field. Minimum of 3 years of experience supporting or leading technical projects within an R&D or bioprocessing environment. Strong problem-solving skills with a proactive, solution-oriented mindset and ability to work independently. Comfortable managing multiple projects simultaneously in a dynamic environment. Effective reporting and presentation skills, with the ability to tailor communication to various audiences. Preferred Experience: Familiarity with aseptic techniques and laboratory best practices. Working knowledge of Good Laboratory Practice (GLP) and scientific method principles. Qualification : Bachelors, Masters, or Ph.D. in Molecular Biology, Biochemistry, Bioengineering, or a related scientific field.

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

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.

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

Technical Lead-Base Level (CTMS Setup) Location: Bengaluru (100% Home-based role) Job Overview: The Technical Lead will be responsible for developing, populating, and supporting templates related to clinical trial payments in the Clinical Trial Management System (CTMS) and other applicable payment systems. The role includes providing assistance and support to Contract & Centralized Services (CCS), business partners, and stakeholders in the use of CTMS for clinical trial payments. This is a fully remote position. Key Responsibilities: CTMS Payment Support: Support the study team training on CTMS payment processes and maintain data entry completeness for clinical trial payments. Issue Resolution & Tracking: Assist with complex issue resolution, resolve failed payments, track issue statuses, and attend meetings to review ongoing issues. Study Setup & Collaboration: Ensure proper study setup in CTMS, collaborate with business partners and stakeholders to address issues and ensure alignment with study goals. Template Creation & Revision: Create or revise payment templates in the CTMS and ensure their accuracy. Issue Management: Support issue resolution via the SAM tool, participate in team meetings, and provide support to other CCS CTMS regions. Adherence to Guidelines: Ensure that all services provided comply with client SOPs, WIs, policies, local regulatory requirements, and ICH-GCP guidelines. Additional Deliverables: Assist with any additional deliverables as assigned to meet project goals and ensure seamless study operations. Qualifications: Education: Bachelor's degree or equivalent in appropriate scientific or business disciplines. Experience: 2-4 years of experience in the pharmaceutical or clinical research industry, specifically in clinical trial payments, pricing, or budgeting. CTMS Experience: Strong hands-on experience with Clinical Trial Management Systems (CTMS) is a must; familiarity with EDC (Electronic Data Capture) systems is a plus. Communication Skills: Fluent in English, with excellent oral and written communication skills. Compliance Knowledge: Familiarity with healthcare compliance and other relevant regulations (e.g., HIPAA, FCPA, Safe Harbor, etc.). Analytical Skills: Strong analytical abilities and problem-solving skills to address challenges effectively. Cross-Functional Collaboration: Ability to work effectively in cross-functional teams and interact with various levels of the organization. PC & Database Management Skills: Proficiency with MS Office suite and database management tools. Work Style: Self-motivated with the ability to work independently and accomplish substantial tasks with minimal supervision. Virtual Work Experience: Previous experience working in a virtual environment and collaborating remotely. Desired Attributes: Innovative Spirit: Ability to bring forward creative solutions to complex problems. Interpersonal Skills: Strong ability to collaborate and maintain positive working relationships with team members and stakeholders. This position offers an exciting opportunity for an individual with a strong background in CTMS, clinical trial processes, and problem-solving abilities, seeking to work in a dynamic and fully remote environment. If you are a motivated professional with experience in clinical trial management and payments, we encourage you to apply. Qualification : Bachelor's degree or equivalent in appropriate scientific or business disciplines.

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: Primary Market Research Senior Consultant Join a global organization with 82000+ employees around the world, as a Primary Market Research Senior Consultant based in Bangalore/ Gurugram/ Pune which helps life sciences companies to accelerate innovation to make greater impact on human health. Our transformative technologies harness intelligence, integrate industry-leading data and analytics. About the team The role is within the Research & Intelligence Team (R&I), whose aim is to deliver market research solutions, comprising mainly of PMR (Primary Market Research) along with inputs from SDR (Secondary Desk Research) to generate relevant insights for clients. Our team: Effectively combines different sources of data and using leading edge PMR techniques and capabilities to generate research, which is actionable, going beyond insight generation to show how to understand and influence prescriber and patient behavior. Role Summary Experience in market research: 7-10 years Manage multiple PMR projects under tight timelines interfacing with global clientele and prioritize requests based on the criticality and business need as agreed with the stakeholders. Responsibilities: Manage multiple PMR (qual and quant) projects under tight timelines interfacing with global clientele and prioritize requests based on the criticality and business need as agreed with the stakeholders. Write questionnaires and discussion guides for diverse stakeholders like physicians, patients, caregivers, payers etc. Create custom market research solutions for clients by thinking through their business issue, and adding the right context to the request (therapy area, methodology etc.). Deliver in depth, comprehensive, regular PMR reports and support ad hoc queries in the areas of indication-based pipeline landscapes, competitor company/ asset profile, competitor launch timelines and key event timelines, newsletters etc. Analyze secondary data sources and reports to provide information on overall market landscapes, market sizing and a range of ad hoc business questions. These analyses may include reporting of the competitive and scientific landscape both in terms of the current position and the predicted future state. Responsible for continuous process improvement in developing content for various PMR deliverables across indications/therapy areas. Demonstrate excellence as an individual contributor with minimal support from peers/team lead, together with the ability to mentor a team of analysts/ACs, driving high productivity/ efficiency, and creating appropriate performance reviews and capability development plan. Quality control and overview and to ensure deliverables are client ready. Project types: Market assessment and sizing, pipeline assessments, patient/consumer journey, brand tracking, go-to-market strategy. What we re looking for: Relevant experience of 7-10 years with master s degree (M.Pharm/MSc in Pharmacy, Biotechnology, life sciences). Exceptional communication skills both at the written and oral level. Excellent knowledge of English and of the main Microsoft Office tools (Word, Excel, PowerPoint). High skills of interpretation and analysis (quantitative, qualitative and integration of different sources of data assets) - This would include thinking through the client business issue, adding the right context to the request (therapy area, business issue etc.) and developing a tailored, innovative solution to address the clients business objectives. The preferred candidate will be creative, client/objective focused, open minded, autonomous and at the same time have great team spirit. Should be aware of free to use online resources like WHO, USFDA, CDC, CMS, PubMed, UNSD, Eurostats, NORD, FDA warning letters, etc.

Job Title: Quality Assurance Analyst Location: Bengaluru Qualifications: BE / Bachelor of Pharmacy / Bachelors of Information Technology Experience Required: Minimum 2 Years About Accenture Accenture is a global professional services company with expertise in digital, cloud, and security. With 699,000+ employees in 120+ countries, we provide Strategy & Consulting, Technology & Operations, and Accenture Song services driving transformation through technology and human ingenuity. Visit us at www.accenture.com Role Overview As a Quality Assurance Analyst, you will work within Accenture s Life Sciences R&D vertical, ensuring compliance, validation, and quality assurance for computerized system applications in pharmaceutical and life sciences operations. You will support hospitals, outpatient clinics, hospices, and other healthcare facilities, ensuring adherence to industry regulations such as GAMP Guidance, 21 CFR, and EU Regulations. Key Responsibilities Validation & Compliance: Perform validation efforts for Accenture projects (system implementation, deployment, validation, and decommissioning). Ensure adherence to FDA regulations and industry standards. Documentation & Project Management: Author and coordinate documentation such as: Test scripts/checklists (IQ/OQ/UAT) Requirements Specification Traceability Matrix System Validation Master Plan Final Validation Report Oversee project management of validation efforts. Team Collaboration & Mentorship: Participate in team meetings and knowledge exchange. Mentor junior members of the Validation Team. Strong experience in Information Management System Testing & Validation Knowledge of Life Sciences CSV (Computer System Validation) Understanding of Life Sciences Automation Enablement Familiarity with regulatory requirements (GAMP Guidance, 21 CFR, EU Regulations) Ability to establish strong client relationships Strong problem-solving and workload prioritization skills Adaptability and flexibility in a fast-paced environment Ability to meet deadlines and work under pressure Work with top pharmaceutical and life sciences companies. Gain expertise in healthcare regulatory compliance. Be part of a dynamic and innovative Life Sciences R&D team. Career growth opportunities in a global organization. Shift Requirement: May require rotational shifts. Qualification : BE / Bachelor of Pharmacy / Bachelors of Information Technology

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...

Principal Architect Location: Bangalore Company: AliveCor About AliveCor AliveCor is on a mission to **revolutionize heart health** by making it accessible to everyone, everywhere. We have pioneered **over-the-counter medical ECG devices**, trusted by millions, and are leaders in empowering consumers to take control of their heart health. With our **FDA-cleared medical-grade hardware and software**, users have performed over 300 million heart health measurements. We are a team driven by a shared passion to make a real difference in people s lives. The Opportunity & Role As the **Principal Architect** at AliveCor, you will play a pivotal role in **shaping the future of heart health technology**. You will lead the architecture of our platform, ensuring it meets the evolving needs of our customers and the healthcare industry. This role requires **strong technical expertise in GoLang, Java, AWS, and modern software architecture**. Key Responsibilities Architect & Design Solutions: Collaborate closely with product and engineering leadership to design **scalable, secure, and efficient solutions** for both consumer and clinician-facing applications. Hands-On Engineering: Actively engage in software development (**up to 50% of your time**), working with technologies such as **Go, Java, Ruby on Rails, PostgreSQL, AWS, React, JavaScript**, and mobile (iOS & Android) apps. AI Integration: Leverage cutting-edge **AI technologies, including LLMs** (Large Language Models), to enhance the customer experience and drive product innovation. Ownership & Scalability: **Own the architecture** for your suite of products, ensuring it aligns with the organization s technical vision and is built to scale. Lead the review process and ensure timely implementation of changes. Mentorship & Best Practices: Drive **code reviews, design reviews, and architecture discussions** to establish and uphold engineering best practices across teams. Backend Infrastructure & Improvement: Maintain and continuously enhance backend systems to solve technical limitations before they affect production. Experiment with New Technologies: Explore emerging technologies and drive adoption where relevant, measuring impact and scalability. Qualifications & Skills Hands-on Engineering Leadership: **15+ years of hands-on software engineering experience**, including significant exposure to architecture and systems design. Core Proficiency: Strong knowledge of **GoLang and Java**, with experience in designing and building large-scale systems. Cloud & Platform Expertise: Expertise in **AWS and Kubernetes**, with the ability to architect and manage cloud-based systems. Architecture Design: Extensive experience with **multi-tier architectures, high-performance web-scale systems, and large databases**. System Design Expertise: Strong system design skills and experience designing clean interfaces and working at the right level of abstraction. Microservices & SOA: Experience designing and implementing **Service-Oriented Architectures (SOA) or Microservices**. CI/CD & Automation: Familiarity with build process automation and **CI/CD** (e.g., GitLab, Travis). Product Focused: Ability to work with product teams to identify customer pain points and iterate on solutions quickly. Willingness to Learn: Eagerness to learn new technologies and adapt to the ever-changing landscape of software engineering. Knowledge of Ruby on Rails is a plus, but not a requirement. Perks & Benefits Working Model: Hybrid Working Model (Flexibility to work both remotely and in the office). Leave: Generous Vacation Policy and comprehensive Family Leave. Medical Benefits: Above-market family floater medical insurance, covering both parents. Office Perks: Complimentary lunch provided at the office and convenient metro connectivity. Culture: Supportive, collaborative team culture.