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    Senior Regulatory Affairs Specialist - Mumbai, India - Meril

    Meril
    Meril Mumbai, India

    1 week ago

    Default job background
    Upper Management / Consulting
    Description

    We are currently seeking a highly motivated and experienced professional in Regulatory Affairs specializing in Medical Devices to join our team.

    Job Titles: Executive / Senior Executive / Assistant Manager - Regulatory Affairs

    Experience: 3 to 9 years

    Location: Andheri east, Mumbai

    Working Days: 6 days (Mon-Sat) - WFO

    Responsibilities:

    1. Dossier collation and submission across the globe for the medical devices for all of the above segments.

    2. Query handling and liase with various Ministries of Health for the approvals of the devices.

    3. Coordination with R&D, Plant Quality Assurance/Regulatory Affairs department for the collation of the dossiers.

    4. Communication with distributors/consultants across the globe to get approvals for the devices.

    5. Coordination with the International Sales Team for the registrations in their respective countries.

    6. Update and maintain the documentation for the submissions at our end and maintain all records.

    7. Maintaining and monitoring the QMS documentation and Preparing for Audits as per individual countries requirement.

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