197 fda jobs in India.

... impurity qualification, extractables and leachable assessments, and product safety profiles. - Monitor evolving global regulations and guidance documents (ICH, FDA, EMA, WHO, and regional requirements) relevant to toxicology and impurity assessment. Required Experience - 3-5 years of experience in toxicology, safety assessment, ...

... liquid manufacturing. - Coordinate with QC/QA for raw material approval in-process checks and final product release. - Ensure compliance with GMP ISO FSSAI / FDA (as applicable) standards. Manpower & Team Management - Manage production supervisors operators and contract workers. - Allocate manpower shift-wise to meet production ...

... up target test environments for Verification & Validation (V&V) activities while maintaining tracking documentation compliant with regulatory bodies (like the FDA) and W3C standards. - Collaborate Across Teams : Work alongside local and distributed engineering teams to improve overall product testability, toolsets, and ...

... the Gulf, Africa and Europe. We source from Sortex-equipped processing partners in Maharashtra and ship out of Nhava Sheva (JNPT). IEC AACCT6731A, APEDA & US FDA registered. Activity on Internshala Hiring since October 2026 1 opportunity posted Additional Questions Sign up to continue Candidate sign up Sign up/ Login with ...

... expertise in relevant technical domains (e.g., diagnostics, biologics, instrumentation) • Strong understanding of quality systems and regulatory requirements (FDA, ISO, GMP) • Experience managing complex projects, budgets and resources • Strong leadership abilities with demonstrated success building and developing teams ...

... knowledge on Standards management and Change Management process of medical devices. - Applied understanding of GDP, ISO 13485 (Must have). - Good understanding of FDA 21CFR Part 820 (Must have) Preferred: - Demonstrated ability to work effectively with various work groups to assure conformance to regulatory requirements, internal ...

... Management Systems (QMS). - Excellent organizational, communication, and problem-solving skills. - Proficiency with Microsoft Office Suite. Preferred Knowledge - FDA 21 CFR Part 11 - 21 CFR Parts 820 - ISO 9001 and/or ISO 13485 - GMP, GDP, Change Control, CAPA, and Risk Management Leadership Responsibilities - Provide day-to-day ...

... Management Systems (QMS). - Excellent organizational, communication, and problem-solving skills. - Proficiency with Microsoft Office Suite. Preferred Knowledge - FDA 21 CFR Part 11 - 21 CFR Parts 820 - ISO 9001 and/or ISO 13485 - GMP, GDP, Change Control, CAPA, and Risk Management Leadership Responsibilities - Provide day-to-day ...

... appropriate verification and validation activities are performed and documented. - Ensure compliance with industry standards and regulations (e.g., ISO 13485, FDA regulations, IEC 62304, cybersecurity requirements, company quality procedures). - Support internal and external audits and ensure the SW bugs (pro-prod and prod) ...

... facility and team members. Key Responsibilities - Manages to ensure compliance fair and consistent administration of the Company policies procedures and USDA/FDA policies. - Is responsible for supporting managing or implementing Food Safety and Product Quality standards. - Leads the Environmental Health and Safety initiatives ...

... considered. - Previous experience with regulated global trials highly preferred. - Demonstrated knowledge and application of clinical requirements, including ISO, FDA, and International requirements. - Demonstrated ability to expand application of clinical and regulatory knowledge to interdivisional projects as needed. - Demonstrated ...

... technical due-diligence and clarification rounds. • Map solutions to regulatory and standards frameworks such as IEC 62443, CERT-In, NCSC CAF, EU CRA, EU AI Act, FDA / EU MDR and IEC 81001-5-1. • Collaborate with delivery partner and product teams (including AI security and OT IDS partners) to build reusable offerings, accelerators ...

... and familiarity with regulated life sciences or clinical research environments. - Preferred: Knowledge of Good Practice (GxP) principles, GAMP 5 guidance, and FDA 21 CFR Part 11 requirements relating to electronic records and electronic signatures. - Preferred: Experience with tools such as Jira, ServiceNow, HP ALM, or ...

... technical due-diligence and clarification rounds.- Map solutions to regulatory and standards frameworks such as IEC 62443, CERT-In, NCSC CAF, EU CRA, EU AI Act, FDA / EU MDR and IEC 81001-5-1.- Collaborate with delivery partner and product teams (including AI security and OT IDS partners) to build reusable offerings, accelerators ...

... dossiers under senior supervision Regulatory Compliance - Use the approved label (SmPC/PI) as the reference for claim boundaries - Apply working knowledge of FDA OPDP, ABPI, and EFPIA guidelines - Flag fair balance and off-label concerns MLR Process & Workflow - Understand the end-to-end MLR lifecycle and the distinct ...

... considered. - Previous experience with regulated global trials highly preferred. - Demonstrated knowledge and application of clinical requirements, including ISO, FDA, and International requirements. - Demonstrated ability to expand application of clinical and regulatory knowledge to interdivisional projects as needed. - Demonstrated ...

... compliance and successful system implementation in context with CSV/CSA.- Ensure alignment of digital systems with regulatory requirements (e.g. ISO 13485, MDR, GxP, FDA 21 CFR).- Support QMS team in additional digital quality-related activities e.g. AI Agent implementation as required by line https://jobeax.com/link/8l1HKAPsCuIcTvHp ...

... understanding of safety database functionality • Solid knowledge of procedural documents and working knowledge of global safety reporting requirements (including FDA regulations and guidelines) • Ability to juggle multiple tasks while still delivering high quality results • Strong attention to detail and accuracy with orientation ...

... substantiation dossier and referencing standards - QA junior reviewers' literature selection and reference accuracy Regulatory Compliance - Apply expert knowledge of FDA OPDP, ABPI, EFPIA, and national codes - Identify explicit and implied off-label risks; assess fair balance across text and design - Guide multi-market claim adaptation; ...

... a plus. - Experience in user interface (UI) design and knowledge of UX principles for hardware/software integration will be an added advantage. - Knowledge of FDA guidelines and compliance requirements for medical devices will be preferred. How we work together: We believe that we are better together than apart. For our ...