Regulatory Affairs Executive

1 month ago


Navi Mumbai, India METSL Full time

We have job opportunity for the position of Regulatory Affairs Executive in our leading manufacturing company.

Location:

- Navi Mumbai

Experience:

- 2 to 3 yrs

Gender:

- Male/Female

Maintain regulatory files. Maintain and update regulatory authorizations, such as IDEs, Medical device licenses, and CE dossiers for certifications etc.
- Documenting technical file for ISO 9001:2005 and Implementing compliance to performance of Medical Device
- Product registrations with supervision, evaluate, prepare and submit medical registrations.
- Reviewing all quality policies and procedures with standard regulatory requirements.
- Successfully implemented quality procedures related to medical device standard - ISO-13485
- Ensure compliance with corporate regulatory processes and internal SOP’s
- Looking over the non conformities of the medical devices and resolving the CAPA procedures
- Handling queries and follow up with regulatory bodies.
- Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance.
- Conducting internal audits.

**Salary**: ₹18,000.00 - ₹25,000.00 per year

**Benefits**:

- Cell phone reimbursement
- Provident Fund

Supplemental pay types:

- Performance bonus



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