Head - Regulatory Affairs - Medical Devices - EU/US Market (5-15 yrs) - New Delhi, India - iimjobs

    iimjobs
    iimjobs New Delhi, India

    2 weeks ago

    Iimjobs background
    Full time
    Description


    Looking at professional experience of min 5 years into Global Regulatory Affairs and who has actively done submissions for global markets such USFDA, ANVISA, etc as the companies plan to expand to Europe and US markets.


    • Incumbent should be carrying strong knowledge of relevant regulations and guidelines for medical devices, including FDA 21 CFR, EU Medical Device Regulation (MDR), and ISO
    • Strong knowledge of relevant regulations and guidelines for medical devices, including FDA 21 CFR, EU Medical Device Regulation (MDR), and ISO 13485.
    • Expertise in the preparation and submission of regulatory filings, such as pre-market clearance or approval applications, to regulatory bodies.
    • Experience with the design control process and ability to review and approve technical documents such as design specifications, testing plans, and protocols.
    • Understanding of the product development process, including design, development, testing, and manufacturing of medical devices.
    • Ability to perform gap analysis and risk management to ensure compliance with regulations and standards.
    • Experience with Quality Management Systems (QMS) and International Organization for Standardization (ISO) requirements.
    • Knowledge of the principles of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
    • Strong analytical and problem-solving skills, ability to evaluate and interpret data.
    • Strong verbal and written communication skills to effectively communicate with internal and external stakeholders.
    • Experience with electronic submission and management systems for regulatory documents.
    • Familiarity with industry standards and guidelines from various regulatory bodies worldwide.
    • Team: 1 member (Team may expand in the future)