Regulatory Affairs Executive

6 days ago


Navi Mumbai, India METSL Full time

We have job opportunity in our leading manufacturing company of Medical devices

Position:

- Regulatory Affairs Executive

Experience:

- 2 to 4 Yrs

The JD as follows:

- 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**: ₹22,000.00 - ₹35,000.00 per month

**Benefits**:

- Cell phone reimbursement
- Provident Fund

Ability to commute/relocate:

- Navi Mumbai, Maharashtra: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- Regulatory reporting: 2 years (preferred)

**Speak with the employer**
+91 9920929438



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