Regulatory Affairs Executive
1 month ago
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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