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Regulatory Affairs Specialist

2 months ago

mumbai, India Meril Full time

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


Positions are: Sr. Executive / Asst. 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 liaise 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.