Regulatory Affairs Expert Jobs in Bengaluru
1585 Jobs Found
General Manager Healthcare RCM Operations
Getix Health
General Manager Healthcare RCM Operations Job Category: Management Location: Bangalore Job Overview We are seeking an experienced General Manager Healthcare RCM Operations to lead end-to-end Revenue Cycle Management (RCM) operations across multiple clients. This leadership role is responsible for strategic planning, operational excellence, client management, team leadership, compliance, and financial performance, ensuring efficiency, accuracy, and client satisfaction in all RCM functions. Key Responsibilities Strategic Leadership Drive strategy, planning, and execution across all RCM functions including patient access, billing, coding, charge capture, claims processing, payment posting, AR follow-up, and denial management. Develop and implement initiatives to improve collections, reduce denials, and optimize cash flow. Align operational strategies with client expectations, regulatory compliance, and industry best practices. Operational Excellence Oversee large-scale RCM operations across multiple clients/accounts. Monitor key performance indicators (AR days, clean claim rate, denial rate, net collection rate, etc.) and drive continuous improvement. Implement process automation and digital transformation initiatives to enhance operational efficiency. Client & Stakeholder Management Serve as the primary point of contact for client leadership. Build strong client partnerships, ensuring SLAs, TATs, and quality standards are consistently met or exceeded. Manage escalations and drive resolutions with a client-focused approach. Team Leadership Lead, mentor, and inspire a large team of managers, SMEs, and associates across functions. Hire, train, and develop leadership talent to ensure a strong succession pipeline. Promote employee engagement, retention, and a performance-driven culture. Compliance & Quality Ensure strict adherence to HIPAA, CMS guidelines, and client-specific compliance requirements. Establish and maintain robust internal controls and audit processes. Collaborate with Quality and Training teams to maintain high accuracy and performance standards. Financial Management Own the P&L for assigned accounts and operations. Drive cost optimization initiatives without compromising service quality. Provide accurate financial forecasts, budgets, and performance reports to leadership. Key Skills & Competencies Deep expertise in US healthcare RCM (front-end to back-end). Strong knowledge of payer rules, coding guidelines, and HIPAA compliance. Proven experience in managing large-scale operations (250+ FTEs). Client-facing leadership with the ability to build CXO-level relationships. Data-driven decision-making with strong analytical and problem-solving skills. Experience driving digital transformation and automation (RPA, AI in RCM). Excellent communication, negotiation, and stakeholder management capabilities. Success Metrics Improvement in collections and AR performance. Reduction in denials and operational errors. Achievement of SLA and client satisfaction targets. Strong employee retention and a robust leadership pipeline. Profitability and cost optimization in line with business objectives.
Senior Regulatory Affairs Specialist
Alivecor India
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
Clinchoice
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 Processing1
Clinchoice
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
Legal Litigation
Kia India Private Limited
Position: Legal Counsel Litigation Location: Bengaluru Experience: 8 14 years Role Overview We are seeking a seasoned legal professional to join our legal team with a strong focus on litigation, contract management, and regulatory compliance. The ideal candidate will have extensive experience handling diverse legal matters, including consumer, IPR, property, and recovery-related litigation, along with expertise in customs and regulatory investigations. This is a high-responsibility role involving cross-functional collaboration, external counsel coordination, and providing strategic legal advice to support business operations. Key Responsibilities Litigation Management Handle litigation across areas including Consumer, IPR, Property, Recovery, etc. Coordinate with external legal counsels, monitor case progress, and ensure effective representation. Oversee case documentation, status tracking, and regular management reporting. Gather feedback and inputs from internal stakeholders to aid legal strategy. Contract Management Draft, review, and negotiate various commercial contracts and agreements. Ensure legal and regulatory compliance in all contractual matters. Provide risk analysis and safeguard company interests in all legal documents. Regulatory & Customs Compliance Deep understanding of Customs laws, DRI investigations, and related regulatory frameworks. Liaise with government authorities and handle inquiries or proceedings as required. Provide legal support for manufacturing and sales-related matters. Legal Advisory Offer proactive legal opinions and strategic counsel to business units on day-to-day operations. Stay updated with relevant laws, regulations, and industry best practices. Candidate Requirements Bachelor s Degree in Law (LLB) from a recognized university; LLM is a plus. 8 to 14 years of relevant experience in litigation and corporate legal functions. Hands-on experience in customs litigation, consumer disputes, and DRI investigations. Strong drafting, negotiation, and analytical skills. Ability to work independently, handle multiple matters, and take initiative. Proficient in English and local language(s); excellent communication skills. Willingness to travel at short notice and relocate within India if required. Demonstrates a flexible, proactive, and committed approach to legal practice. Preferred Skills Litigation strategy and court representation External counsel management Contract negotiation and risk mitigation Regulatory knowledge (Customs, DRI, Sales, Manufacturing laws) Business-oriented legal advisory Join us and contribute to protecting and growing our business through strategic legal leadership. Apply now to be a key pillar in our legal team. Qualification : Bachelors Degree in Law (LLB) from a recognized university; LLM is a plus
Technical File Reviewer
Sgs India Private Limited
Job Title: Personal Protective Equipment (PPE) Products Technical File Reviewer Location: Bangalore Employment Type: Full-time Company Overview: SGS is the world s leading testing, inspection, and certification company. Recognized as the global benchmark for sustainability, quality, and integrity, we operate a network of 97,000 employees across 2,650 offices and laboratories worldwide. Our mission is to enable a better, safer, and more interconnected world by delivering expert solutions that make businesses more efficient and compliant. Position Summary: We are seeking a Technical File Reviewer for PPE products to join our team in Bangalore. The role involves reviewing technical documentation for various PPE categories in line with European legislation and CE marking requirements. The ideal candidate will have a strong technical background in PPE manufacturing, auditing, testing, or inspection, and be familiar with relevant performance standards. Key Responsibilities: Conduct thorough reviews of client technical files across various PPE product lines such as gloves, protective clothing, footwear, and respiratory masks Ensure documentation aligns with applicable performance standards and European regulatory requirements, including CE marking Coordinate effectively with SGS UK and affiliated notified bodies to manage certification processes Draft certificates upon successful review and support timely delivery Respond to client inquiries and provide clear, accurate updates on certification status Maintain high standards of accuracy, organization, and documentation quality Collaborate with internal and external stakeholders to resolve issues smoothly and efficiently Key Skills and Competencies: Strong understanding of PPE products and associated technical standards Familiarity with European PPE legislation, CE marking requirements, and certification processes High attention to detail with an analytical mindset Excellent written and verbal communication skills in English Proficiency in Microsoft Office and general computer literacy Ability to plan, prioritize, and manage multiple technical reviews under deadlines Professional, cooperative, and customer-focused demeanor Qualifications: A technical qualification in a relevant field (engineering, textiles, materials science, etc.) is preferred Work experience in PPE product manufacturing, auditing, inspection, or testing is essential Prior exposure to reviewing certification files and working with notified bodies is highly desirable
Legal Senior Manager
Jindal Aluminium
Position: Legal Senior Manager Department: Corporate Affairs Location: Bengaluru Role Overview: We are seeking an experienced Senior Manager Legal to provide strategic and proactive legal support to senior management. This role will oversee a broad spectrum of legal matters including corporate governance, regulatory compliance, contract management, intellectual property protection, and dispute resolution to safeguard the company s interests and ensure regulatory adherence. Key Responsibilities: Provide expert legal counsel to senior leadership on corporate governance, regulatory issues, contracts, intellectual property, and other business matters. Ensure company compliance with applicable local, national, and international laws and regulations, including environmental, safety, labor, and IP laws. Keep leadership informed on legal risks, regulatory changes, and emerging issues affecting the business. Draft, review, and negotiate a wide range of commercial contracts such as manufacturing agreements, supplier contracts, distribution deals, and joint ventures. Manage and oversee legal disputes, litigation, and arbitration processes, coordinating with external counsel as required. Advise on the protection and enforcement of intellectual property rights, including trademarks, patents, copyrights, and trade secrets. Provide legal guidance on labor and employment matters, ensuring compliance with labor laws, managing employee relations, and supporting union negotiations. Qualifications: Bachelor of Laws (LLB) degree from a recognized institution. Proven experience in corporate legal practice with expertise in compliance, contracts, IP, and labor law. Strong negotiation, drafting, and communication skills. Ability to provide clear, practical legal advice aligned with business objectives. Qualification : Bachelor of Laws (LLB) degree from a recognized institution.
Manager Legal
Jindal Aluminium
Position: Manager Legal Department: Legal and Corporate Relations Location: Bengaluru Role Overview: We are looking for an experienced Manager Legal to manage litigation and non-litigation legal matters, with a strong focus on land revenue issues, property disputes, regulatory compliance, and contract management. The ideal candidate will possess in-depth knowledge of land laws, property documentation, and dispute resolution, ensuring the company s legal interests are effectively safeguarded. Key Responsibilities: Oversee and manage all legal matters related to the company, ensuring compliance with applicable laws and regulations. Handle legal issues related to land revenue, including land acquisition, property registration, title verification, and encumbrance checks. Ensure compliance with state and central land revenue laws, municipal regulations, and other relevant legal frameworks. Manage land dispute resolution by coordinating with local authorities and providing legal representation in court or other forums as required. Handle litigation matters, including preparation of case files, drafting of petitions, affidavits, and legal submissions. Represent the organization in court proceedings, arbitrations, and other legal forums. Draft, review, and negotiate legal documents such as sale deeds, lease agreements, Memorandums of Understanding (MoUs), and other land-related contracts. Conduct legal due diligence on property transactions to ensure clear title ownership and risk mitigation. Collaborate with cross-functional teams to facilitate smooth property transactions and legal compliance. Provide timely legal advice on various company matters as required. Manage relationships and coordinate with external legal counsel for both litigation and non-litigation matters. Maintain and update legal documentation, property records, and compliance registers to ensure accuracy and accessibility. Qualifications: Bachelor of Laws (LLB) degree from a recognized institution. Proven experience handling land revenue laws, property documentation, and dispute resolution. Strong litigation management skills with the ability to represent the company effectively. Excellent negotiation, drafting, and communication skills. Ability to work collaboratively with internal teams and external legal advisors. Qualification : Bachelor of Laws (LLB) degree from a recognized institution.
Legal Associate
Rubrik
Legal Associate Location: Bengaluru, India About the Team Rubrik s Legal Team is seeking a motivated and talented Legal Associate with a strong interest in corporate and compliance matters, eager to contribute in a fast-paced, dynamic in-house environment. Reporting to the Director of Corporate Legal, this role is based at our Bangalore office within a cutting-edge data security company (NYSE: RBRK). About the Role As a Legal Associate at Rubrik, you will play a key supporting role across various legal functions. You ll thrive in a fast-moving environment, assisting the legal team with corporate governance, compliance, and transaction-related matters, while helping to build scalable legal processes. What You ll Do Support corporate governance activities, including managing filings, board and shareholder matters, and equity-related projects. Assist with corporate transactions such as M&A, financings, and capital market deals. Help develop and maintain company-wide legal and compliance processes to ensure regulatory adherence. Organize and manage multiple corporate and compliance-related tasks and workflows. Implement and maintain legal technology platforms and tools, including artificial intelligence solutions. Experience You ll Need Law degree with a solid understanding of legal concepts and terminology. Prior experience at a reputable technology company is preferred. Excellent written and verbal communication skills. Highly organized with a keen eye for detail. Passionate about legal technology, data security, and AI advancements. Ability to collaborate effectively across teams and departments. Open to coaching and feedback, with a proactive, independent working style. Proficient in Microsoft Office and Google Workspace tools. Join Us in Securing the World's Data Rubrik (NYSE: RBRK) is on a mission to secure the world s data through Zero Trust Data Security . Powered by machine learning, Rubrik Security Cloud protects data across enterprise, cloud, and SaaS applications, helping organizations ensure data integrity, availability, continuous risk monitoring, and swift recovery from cyberattacks and disruptions.
Business Analyst Associate
Deloitte
Job Title: Business Analyst Associate Location: Bengaluru Experience Required: 8+ years Education: BE/B.Tech/MBA Domain Knowledge: BFSI (Banking, Financial Services, and Insurance) Certifications: Certification in Business Analysis (e.g., CBAP, PMI-PBA) Notice Period: Less than 60 days Job Overview: As a Business Analyst Associate, you will support the analysis and design phases of projects by collaborating with business stakeholders to understand their needs and translate them into actionable solutions. Your role will focus on the pre-initiation, initiation, and design stages, working closely with business and technical teams. You will help validate solutions, support User Acceptance Testing (UAT), and drive change adoption for CLIENT programs and projects. Key Responsibilities: Requirement Elicitation Engage with stakeholders, including business users, management, and subject matter experts, to gather detailed business requirements. Conduct interviews, workshops, focus groups, surveys, and observations to document stakeholder needs. Utilize various elicitation techniques like brainstorming, document analysis, and prototyping to uncover business requirements. Requirement Analysis Analyze and prioritize business requirements to ensure alignment with business objectives and project goals. Break down high-level business and user requirements into functional and non-functional requirements. Identify gaps, inconsistencies, and conflicts in requirements and collaborate with stakeholders to resolve them. Documentation Create comprehensive documentation, including Business Requirements Documents (BRDs), Functional Specifications, Use Cases, User Stories, and Process Flow Diagrams. Maintain clear and concise documentation for ease of understanding and accessibility to all stakeholders. Stakeholder Communication Act as a liaison between business stakeholders and technical teams to ensure effective communication and a shared understanding of requirements. Facilitate meetings, presentations, and workshops to communicate findings, project updates, and recommendations. Solution Design & Implementation Collaborate with development teams to translate business requirements into functional specifications and technical requirements. Participate in designing and implementing solutions that meet business needs and improve operational efficiency. Provide input during design reviews to ensure solutions align with business requirements. Testing and Quality Assurance Develop and execute test plans, test cases, and test scripts to ensure that solutions meet business requirements and are defect-free. Conduct User Acceptance Testing (UAT), gather feedback, and refine solutions accordingly. Document and communicate test results to stakeholders. Data Analysis & Reporting Perform data analysis to support business decisions and provide actionable insights. Create and maintain dashboards, reports, and visualizations to track KPIs and project progress. Project Management Support Manage project timelines, deliverables, and resources to ensure successful project completion. Monitor and report on project progress, including risks, issues, and changes. Coordinate with project managers to ensure alignment with project plans and schedules. Continuous Improvement Identify opportunities for process improvements and recommend solutions to enhance business performance. Promote a culture of continuous improvement and innovation within the team and organization. Stay updated on industry trends and best practices to drive business improvements. Training & Support Provide ongoing support and training to stakeholders on new systems, processes, and tools. Develop training materials and conduct sessions to ensure successful adoption of solutions. Act as a point of contact for post-implementation support and troubleshooting. Industry and Domain Knowledge Stay updated on industry trends, regulatory changes, and best practices related to BFSI. Apply domain knowledge to ensure solutions align with industry standards and regulatory requirements. Domain Expertise Required: You should have experience in the following areas of Banking Operations: Wealth and Private Banking (Retail Banking) Retail lending and investing concepts Mortgage and credit card processes Contact Center Optimization (IVR, browser changes under digital channels) Branch optimization Payments International Payment Systems and Open-Banking API-driven payments End-to-End payment lifecycle experience Corporate payments, cash management, real-time/immediate payments ISO 20022 migration experience Investment and Commercial Banking (CMB) Corporate and cash management core products and services Trade operations, market liquidity, and capital flow Knowledge of regulatory issues and Automated Data Flow projects (e.g., RBI automated reporting systems) Skills & Qualifications: Educational Background: Master s degree in Business Administration or related field. Certifications: CBAP, PMI-PBA, or other relevant business analysis certifications. Technical Knowledge: Strong understanding of the Software Development Life Cycle (SDLC) and technical project management. Data Analysis Tools: Experience with tools like Excel, SQL, or Tableau for data analysis and visualization. Project Management Methodologies: Familiarity with Agile or Waterfall methodologies. Domain Expertise: Experience in Banking and Financial Services (BFSI), particularly in leading or participating in end-to-end digital transformation programs in Agile environments. Additional Expertise for Specific Projects: For Market Business Analysis (BA), the focus will be on analyzing business challenges and identifying requirements for digitization, especially in Agile environments (CSM certified, SAFe methodology). You will manage backlogs, engage stakeholders, and support market adoption efforts. For Digital Business Analysis (BA), you will collaborate with technology teams to ensure the solutions meet business needs. You'll work w...
Grc Specialist
Locus
Job Title: GRC Specialist Location: Bangalore (On-site; full-time) About Locus: At Locus, we are redefining logistics decision-making with deep-tech solutions that drive efficiency, consistency, and transparency across industries like retail and FMCG/CPG. Founded in 2015 by Nishith Rastogi and Geet Garg, Locus has evolved from a women s safety geo-tracking app into a globally recognized logistics optimization platform. Our technology has empowered enterprises such as Unilever and Nestl to execute over a billion deliveries across 30+ countries. Guided by our commitment to innovation and sustainable growth, we transform complex supply chains into strategic growth enablers. Join us at Locus and be part of a team shaping the future of global logistics. Job Overview: About the Role Governance Risk and Compliance Specialist (GRC Specialist) We're looking for a candidate with 2-4 years of relevant experience. Key Responsibilities: Define, implement, and maintain the Information Security Management System (ISMS) and Privacy Information Management System (PIMS). Plan and execute periodic risk assessments. Work directly with the business units to facilitate risk assessment and risk management processes. Define, Review and Maintain the organizational information security policies, processes, procedures and control framework to ensure it is adequate to address the emerging risks due to changing environment, technology and legal requirements. Align customer and internal information security objectives to the ISMS and PIMS. Monitor and fulfill client contractual (MSA) information security and privacy obligations. Monitor and fulfill legal obligations related to protection of personal information across different jurisdictions like GDPR, CCPA. Prepare metrics based periodic reports and dashboards with support from the stakeholder functions for management review. Liaise with security vendors, suppliers, service providers and external resources for new security tools for improving security. Lead the Information Security audits / assessments / remediation and present key risks to the management. Perform the Third party Risk Assessment of Critical Vendors. Conduct Information Security and Privacy awareness and training programs for the employees as part of their induction and regular awareness. Oversee information security and privacy incident management process for incident reporting, containment, resolution and root cause analysis. Plan and coordinate BCP and DR tests. Setup guidelines for secure coding practices. Recommend security and privacy controls based on people, process and technology approach and industry best practices. Identifying solutions or writing automation scripts for solving regular tasks or optimizing processes. SOC Monitoring Activities such as. Firewall, Vulnerability, Inspector, Guarduty etc. Log Review, Incident Handling & Compliance adherence. Qualifications: Good understanding of information security compliance requirements like ISO27001, SOC2, CSA STAR and Privacy requirements like BS10012 & ISO27701. Good understanding of legal obligations towards protection of personal information across different jurisdictions like GDPR, CCPA, etc. Experience in creating and auditing security and privacy best practices and implementation of security and privacy principles across organization, to meet business goals along with customer and regulatory requirements. Experience implementing security and privacy controls for cloud platforms like AWS, Azure. Experienced in solving Audit and Regulatory Issues. Experience in auditing MDM, SSO solutions, AWS (Cloud Infra), Firewall, WAF, DLP etc. Good at solving information security compliance challenges by recommending solutions and best practices. Join Locus and become part of a visionary team that is redefining logistics through innovation and smart distribution. We provide competitive compensation, comprehensive benefits, and a collaborative environment where your expertise will drive both your growth and that of the organization. Locus is an equal opportunity employer dedicated to creating a diverse and inclusive workplace.
Analyst / Associate Finance Controller
Falconx
FalconX is a pioneering team of operators, investors, and builders dedicated to redefining institutional access to the cryptocurrency markets. Sitting at the nexus of traditional finance and cutting-edge technology, FalconX tackles the industry's biggest challenges. The digital asset space is complex and fragmented, offering limited products and services that cater to the sophisticated trading strategies and liquidity requirements common in conventional financial markets. FalconX delivers a comprehensive, all-in-one solution for institutional clients supporting their digital asset strategies from inception to scale. Acting as the connective tissue for the ecosystem, we empower clients to seamlessly navigate the ever-evolving crypto landscape. Role: Analyst/Associate - Finance Experience: 3-8 Years Qualification: Chartered Accountant (CA) or CPA Key Responsibilities Accounting & Financial Reporting Execute day-to-day accounting, bookkeeping, and reporting as per relevant GAAP standards (US GAAP, IndAS, IFRS). Prepare and review monthly, quarterly, and annual financial statements for both standalone and consolidated entities. Assist in handling complex technical accounting matters including Revenue Recognition, Consolidation, Stock Options, Business Combinations, MTM accounting, and more. Legal Entity Management Manage jurisdiction-specific accounting, reporting, and compliance for assigned legal entities. Monitor and settle inter-company balances, and oversee transfer pricing arrangements. Operations & Reconciliation Develop an in-depth understanding of FalconX s trading and settlement processes. Support the Trade Operations & Settlements team by performing daily, weekly, and monthly reconciliations and attestation procedures. Process & Control Framework Assist in establishing and improving internal processes, policies, procedures, and control frameworks. Collaborate with external auditors, the audit committee, and other internal/external stakeholders during audits and reviews. ERP & Systems Expertise Leverage hands-on knowledge of ERP systems (such as NetSuite, Oracle, SAP), ensuring system integrity and efficiency across finance and reporting processes. What Success Looks Like Build robust in-house accounting and reporting capabilities to support FalconX s growth. Streamline finance processes to ensure real-time, accurate financial information for stakeholders. Effectively manage legal entities across jurisdictions, ensuring all regulatory, statutory, tax, and management reporting is timely and compliant. Collaborate closely with trading and trade operations teams, proactively aligning financial processes with business dynamics. Grow into a Subject Matter Expert (SME) in financial, regulatory, and operational aspects of crypto trading and digital assets. Balance multiple responsibilities, adapting to new challenges while maintaining high-quality outcomes. Required Qualifications & Skills Professional Degree: Chartered Accountant (CA) or CPA (mandatory). Experience: 3-8 years in relevant industries Banking, Broker-Dealer, Trading, or FinTech. Legal Entity Management: Proven experience handling end-to-end deliverables of legal entities, including transfer pricing arrangements. Expertise in IFRS, US GAAP reporting standards, with practical experience applying these standards. Proficiency in ERP systems (NetSuite, Oracle, SAP) and MS Excel Finance. Strong understanding of E2E trade flow, including settlements and market-making processes. Excellent analytical and problem-solving skills, coupled with attention to detail and strong communication abilities (written and verbal). Enthusiastic self-starter with the ability to multi-task, prioritize, and deliver under pressure. Keen interest in FinTech, blockchain, and digital assets, with a passion for continuous learning and cross-functional collaboration. Opportunity to work at the cutting edge of finance and technology, shaping the future of institutional crypto markets. Collaborate with a high-performing, global team of experts from top-tier financial institutions and technology firms. Be part of a fast-paced, high-growth environment, where innovation and agility are celebrated. Qualification : Professional Degree: Chartered Accountant (CA) or CPA (mandatory)
Sales Lead - Banking & Capital Markets
Quantiphi
About Us At Quantiphi, technology drives our innovation, but our global and diverse culture powers our success. We take immense pride in fostering a workplace built on transparency, diversity, integrity, continuous learning, and personal growth. If you are excited to work in an environment that encourages innovation and excellence in both professional and personal spheres, Quantiphi could be the perfect place for your career! Role: Client Solutions Partner Banking & Capital Markets Who We Are Looking For We are looking for a highly motivated and experienced sales leader to drive business growth in the Banking & Capital Markets sector across North America. You will report directly to the Senior Client Solutions Partner for Financial Services & Insurance. This role requires: Strong industry knowledge Relationship-building expertise Proven ability to manage large enterprise accounts, especially within Fortune 1000 companies Key Responsibilities Strategic Account Growth Develop and implement account strategies for large Banking & Capital Markets clients in North America Identify and pursue new business opportunities while fostering relationships with C-level executives Sales Cycle Ownership Manage end-to-end sales cycles, from lead generation and analysis to proposals, negotiations, and deal closure Present Quantiphi s value proposition to senior executives, demonstrating clear ROI Client-Centric Solutions Understand client needs, business goals, and technology ecosystems Showcase how Quantiphi s AI and data science solutions can address key challenges such as: Anti-money laundering (AML) Know-your-customer (KYC) Loan origination Fraud detection Risk management Regulatory reporting Investment strategies Personalized banking services Relationship Building Build trusted partnerships with key stakeholders within target accounts Deliver strategic insights on using AI and data to enhance business performance Cross-Functional Collaboration Work closely with internal teams, including marketing, solution architects, and delivery teams, to ensure seamless project delivery and client satisfaction Collaborate with technology and business alliance partners to enhance solution offerings Sales Forecasting & Performance Maintain accurate sales forecasts and effectively manage your pipeline Consistently achieve or exceed assigned sales targets Industry Expertise Stay updated on Banking & Capital Markets trends, including fintech innovations, regulatory changes, and emerging technologies Use this expertise to identify growth opportunities and strengthen Quantiphi s market position Required Qualifications Proven enterprise sales success within Banking & Capital Markets Strong existing network within North America s Banking & Capital Markets sector, preferably with Fortune 1000 contacts Deep understanding of banking business challenges and how AI and data science apply Excellent communication, presentation, and influencing skills across all levels Experience managing complex sales cycles and closing large enterprise deals Strong collaborative approach with the ability to manage multiple stakeholders Bachelor s degree required; MBA preferred Minimum 5 years of enterprise sales experience in Banking & Capital Markets Qualification : Bachelors degree required; MBA preferred
Quality Assurance Analyst
Accenture India
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
Sr. Associate Legal
Centillion Solutions And Servic
Job Description: We are looking for an experienced and highly skilled legal associate to join our Legal Team. You will be responsible for handling a wide range of contracts for our organization. You will collaborate with various internal departments and external stakeholders to draft and negotiate agreements and arrangements being entered into by the organization and provide legal advice to protect the Company s interest. Key Responsibility Areas: Work closely with the business teams to understand the legal requirements of our business. Review and negotiate contracts in accordance with the company standards. Review of customer contracts which includes MSA, SaaS, Annual Maintenance Services Agreement, Software License Agreement. Review of vendor, staffing, Business Correspondent, Lease and other contracts concerning banking and mortgage industry. Maintaining Intellectual Property portfolio especially trademarks and copyrights. Assist with external legal counsels and law firms in the event of any litigations Identify and solve areas of legal assistance to ensure seamless roll-out of new offerings. Manage contracts and maintain the reports relating to upcoming renewals. Maintain the repository of all executed contracts along with the key features of each contract, including all differences from our master contract. Make recommendations and support the operations team on legal documentation to reflect business teams taking into consideration for mitigating risks. Prepare and maintain monthly reports regarding the legal contracts and share the same with the management. Assist in procurement of any corporate certificates as may be needed. Assist in drafting any notices and letters for any delayed payments or disciplinary actions. Provide legal opinions on queries raised by business teams on an as-needed basis Work with various departments (HR, Admin, Finance) and act as advisory body on legal matters. Work on procurement of the insurance policies for the company and keep a track of the renewals. Work with external counsels for their opinions as needed. Research on matters concerning the applicability of the applicable laws to the business and advise the management accordingly. Identify any risk that may be prevalent and propose means to rectify it. Work closely with the leadership team in identifying components that should potentially be added to the master contract. Negotiation of contracts with customers, service providers and vendors. Ensure that the company s interests are protected when negotiating the contract. Uploading contracts, SOW, Work Orders in the inhouse contract management tool and tracking the contract deadlines Any other legal duties that may be required to be fulfilled by you as part of your role. Requirements: Eligibility: 5-7 years total experience as a Legal Counsel in corporate Skills: Excellent written and verbal communication and presentation skills Driven and motivated. Should be able to independently solve complex problems Strong analytical logical reasoning skills Good team player, positive attitude and eager to learn Meticulous attention to detail Data Driven approach Time management skills are imperative to success. High level of customer service orientation required Qualification : 5-7 years total experience as a Legal Counsel in corporate
Compliance Executive
Ricago
Responsibilities: Regulatory Decoding & Analysis: Decode and interpret RBI, SEBI, and other regulatory circulars and notifications to ensure compliance with relevant legal frameworks. Compliance Checklist Preparation: Prepare and maintain comprehensive compliance checklists for various laws, including corporate, labour, HR, EHS, and taxation, ensuring regular updates based on changing regulations. Compliance Audits & Gap Assessments: Plan and execute compliance audits and gap assessments for various clients, ensuring they meet regulatory and legal requirements. Client Consulting: Provide compliance consulting services to clients in areas such as corporate governance, taxation, HR, labour laws, and industrial relations laws. Industry-Specific Compliance: Understand and advise clients on location-wise and industry-specific compliance requirements, supporting the implementation of compliance programs. Regulatory Updates & Impact Analysis: Keep clients informed about changes in the regulatory regime and assess the impact of these changes on their operations. Content Review & Newsletter Preparation: Review content libraries related to compliance checklists, prepare newsletters on recent legislative updates, notifications, circulars, and regulations, and create blogs on compliance-related topics. GRC Platform Support & Implementation: Work closely with the Product & Implementation teams for the successful implementation of Governance, Risk, and Compliance (GRC) platforms, including testing and conceptualizing new modules or changes. Ongoing Checklist Updates: Continuously update compliance checklists as and when new regulations or laws are introduced, ensuring that the content is current and accurate. Ad-hoc Tasks: Take on additional tasks as assigned to ensure the smooth functioning of the compliance and regulatory consulting process. Qualifications: Experience: 4+ years in compliance management, legal consulting, or GRC consulting with strong knowledge of regulatory frameworks like RBI, SEBI, taxation, labour, HR, and EHS laws. Skills: In-depth knowledge of compliance requirements and legal regulations. Strong analytical and research skills to decode and interpret regulatory notifications. Experience in preparing and maintaining compliance checklists and conducting audits. Ability to advise clients on complex compliance matters and stay updated on regulatory changes. Excellent written and verbal communication skills for creating reports, newsletters, and blogs. Experience in working with GRC platforms and collaboration with product teams for platform enhancements. Education: A degree in Law, Compliance, Business Administration, or a related field. Additional certifications in GRC or regulatory compliance are highly desirable.
Sr. Regulatory Technical Program Manager
Ericsson-worldwide
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.
Internal Auditor - Operations
Hp
Description - We are seeking an experienced Internal Audit Principal Auditor with a specialization in Order to Cash (O2C) and a strong focus on Sarbanes-Oxley (SOX) compliance. The successful candidate will lead and execute internal audit engagements within the Order to Cash process, ensuring adherence to SOX requirements and identifying opportunities for process improvement and risk mitigation. What an Internal Audit SOX Principal Auditor does at HP: Oversee aspects of the O2C SOX compliance program in accordance with SOX and PCAOB standards, including scoping, planning, execution, and reporting. Ensure alignment with regulatory requirements and industry best practices. Perform risk assessments and design audit procedures to address key risk areas within the O2C process. Assess the effectiveness of internal controls within the O2C cycle, identifying control gaps, weaknesses, and areas for enhancement. Collaborate with process owners to implement remediation plans and drive continuous improvement. Communicate audit findings, recommendations, and risk insights to senior management and key stakeholders. Provide timely updates on audit progress and ensure alignment with organizational objectives. Lead a team of audit professionals, providing guidance and mentorship to enhance their skills. Provide technical guidance and professional development to junior staff, fostering their growth within the audit function. Collaborate with control owners to identify and document changes to internal controls, ensuring alignment with evolving business processes and regulatory requirements. Coordinate with auditors and co-sourcing partners for controls testing and process walkthroughs. Streamline audit impact on business operations and align test results for efficiencies. Take the lead in implementing effective project management strategies within the O2C SOX compliance program. Develop and implement robust project management methodologies tailored to the specific needs of SOX compliance activities. Ensure accurate tracking of compliance activities and deadlines, maintaining the project management framework to support ongoing SOX initiatives. Review and assess reported control deficiencies with business process owners. Identify root causes and collaborate on corrective actions to strengthen internal controls. Recommend improvements to enhance key controls, driving ongoing optimization of the SOX program. Lead various SOX meetings, facilitating discussions and decision-making processes to support compliance objectives. Work with IT and Compliance teams to ensure alignment with SOX requirements, fostering cohesive compliance efforts. Prepare and present SOX findings and assertions to both the SOX PMO and HP Leadership Team, providing insights for enhancing control effectiveness. Continuously improve the SOX program through optimization and automation initiatives, leveraging technology and best practices. Provide support for internal audit projects, addressing control-related issues and contributing to overall assurance efforts. Individuals who do well in this role at HP, usually possess: Minimum of 8+ years of progressive experience in Internal Audit, Finance, Business management, Accounting, or a related field preferably with exposure to Sarbanes-Oxley (SOX) compliance and Order to Cash (O2C) processes. Experience in public accounting or working with publicly listed companies may also be beneficial. Bachelor's degree in accounting, finance, business management, or a related field. A professional certification related to internal audit or accounting is preferred, such as: Certified Internal Auditor (CIA) Certified Public Accountant (CPA) Certified Information Systems Auditor (CISA) Chartered Accountant (CA) Demonstrated expertise in Sarbanes-Oxley (SOX) compliance, including in-depth knowledge of regulatory requirements such as Sections 302 and 404, and proficiency in internal control frameworks like COSO. Extensive understanding of the Order to Cash process, spanning sales order processing, credit management, invoicing, and revenue recognition, ensuring comprehensive control management. Competency in audit methodologies, with a focus on risk assessment, planning, execution, and reporting, along with the ability to tailor audit procedures for the O2C process. Robust project management capabilities, encompassing effective project planning, resource allocation, stakeholder engagement, and timely delivery of objectives within SOX compliance initiatives. Excellent communication skills, both verbal and written, enabling clear conveyance of findings, recommendations, and insights to stakeholders at all levels, including senior management. Prior experience and proven leadership in managing audit teams, fostering collaboration, and driving continuous improvement within the compliance function. Proficiency in SOX compliance tools and Microsoft Office applications, facilitating efficient compliance processes and documentation management. Strong analytical aptitude to assess control effectiveness, identify deficiencies, determine root causes, and propose effective remediation actions, ensuring robust risk mitigation. Up-to-date knowledge of regulatory developments in SOX compliance and O2C processes, with adaptability to evolving standards to maintain compliance alignment. Solution-focused problem-solving capabilities to address complex control issues encountered during compliance processes, driving effective resolutions and improvements. Proactive mindset towards continuous improvement, emphasizing optimization through automation, standardization, and adoption of best practices to enhance efficiency and effectiveness. Ability to collaborate effectively with cross-functional teams, providing strategic guidance for complex business transactions across multiple countries, ensuring alignment with compliance objectives and business goals. Candidates should be okay with 1) Individual contributor role 2) Hybrid model of work...
Connectivity Architect / Senior Engineer
Hp
Job Title: Connectivity Architect / Senior Engineer Company & Team Overview: HP s vision is to create technology that makes life better for everyone, everywhere every person, every organization, and every community around the globe. With the heart, creativity, and energy of a startup, and the brain, muscles, and determination of a Fortune 100 corporation, we continue to deliver ground-breaking new technologies to build on our 80+ year legacy of innovation. As we look at the future, HP's expansion will increasingly hinge on high-growth countries, necessitating a tailored approach with local product and technology solutions. The mission of the India & Growing Market Development Center is to develop products and solutions geared towards fuelling rapid growth in India. Our team's overarching objective is to create solutions tailored specifically for India and in India! Position Overview: We are seeking a skilled and experienced Senior WWAN M.2 Architect/ Integration Engineer to lead the integration of WWAN (Wireless Wide Area Network) /BT WLAN solutions for M.2 modules in our product lineup of Laptop/PC/IOT. The ideal candidate will have a deep understanding of cellular technologies (4G/5G), WLAN, BT, RF design, hardware integration, and be able to work collaboratively across teams to deliver highly reliable connectivity solutions. Key Responsibilities: Integration: Lead the design and integration of WWAN /BT/ WLAN solutions, focusing on M2 module and other form factor integration, ensuring optimal performance, reliability, and compliance with regulatory standards Hardware Integration: Collaborate with hardware, firmware, and software teams to integrate M2 WWAN/ BT /WLAN modules into various product architectures, including laptops, tablets, and IoT devices Performance Optimization: Analyze and optimize WWAN M2 / BT /WLAN performance, signal quality, and data throughput across multiple cellular standards (4G LTE, 5G NR) and bands Testing and Validation: Develop and execute comprehensive test plans for WWAN M2 modules, working closely with QA and validation teams to resolve issues related to RF performance, connectivity, and regulatory compliance Compliance and Certification: Ensure compliance with global regulatory standards (FCC, ETSI, etc) and participate in certification processes to meet market and carrier requirements Experience in Bluetooth coexistence management, especially with Wi-Fi and other wireless protocols Bluetooth Integration: Oversee the integration of Bluetooth modules into PC/laptop platforms, ensuring seamless functionality, compatibility, and adherence to industry standards Performance Optimization: Analyze and optimize Bluetooth performance, including power consumption, signal quality, latency, and coexistence with other wireless technologies (WLAN, WWAN) Troubleshooting and Debugging: Diagnose and resolve complex Bluetooth-related issues, performing root cause analysis to ensure stable, high-quality user experiences Familiarity with Bluetooth SIG compliance, regulatory standards, and certification processes Expertise in debugging and troubleshooting complex Bluetooth and RF issues Troubleshooting and Debugging: Diagnose and troubleshoot complex WWAN-related issues, ensuring effective root cause analysis and resolution Stakeholder Collaboration: Work closely with suppliers, carriers, and regulatory bodies to ensure M2 WWAN module compatibility and compliance Documentation: Maintain detailed documentation of designs, processes, and testing results, ensuring knowledge sharing and adherence to industry best practices Basic Qualifications: Bachelor s or Master s degree in Electrical Engineering, Telecommunications, or a related field 14+ years of experience in WWAN technology, specifically focused on hardware/ SW integration and cellular networks Proven expertise with M2 modules, cellular standards (4G LTE, 5G NR), and RF design principles Experience in debug, triage and interface stability, ability to work with the module /SoC vendor to be able to isolate the issues and drive them to deliver solutions for the problem Proficiency with tools for RF testing, signal analysis, and validation (eg, spectrum analyzers, network analyzers) Bachelor s or Master s degree in Electrical Engineering, Telecommunications, or a related field 5+ years of experience in WLAN technology, focusing on integration and system-level performance Strong understanding of Wi-Fi standards (80211 a/b/g/n/ac/ax), RF design, and antenna placement considerations Experience with WLAN testing tools and RF signal analysis equipment (eg, spectrum analyzers, network analyzers) Preferred Qualifications: Familiarity with regulatory requirements and industry standards for cellular communications (FCC, PTCRB, GCF) Experience with modem and SIM card integration, cellular carrier certifications, and network testing Familiarity with regulatory standards and certification processes (FCC, CE, IC, etc) Proven experience in advanced debugging and troubleshooting of WLAN /BT connectivity issues Knowledge of security protocols and authentication methods for enterprise-level Wi-Fi networks Excellent communication and teamwork skills for effective cross-functional collaboration Strong problem-solving skills, with the ability to work in fast-paced environments and meet tight deadlines Qualification : Bachelors or Masters degree in Electrical Engineering, Telecommunications, or a related field
Senior Regulatory Specialist
Philips
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.
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