Regulatory Affairs Executive
19 hours ago
Dear Candidates,
We have job opportunity for the position of Regulatory Affairs Executive & QMR in our leading manufacturing Medical Devices companies.
Position:-Regulatory Affairs Executive & Quality Management Representative
Experience:-1 to 3 yrs
Gender:-Male/Female
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.
· Prepare and submit internal regulatory file applications and supporting documentation.
· 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
Interested candidates kindly share your updated CV ASAP.
Job Type: Full-time
Pay: ₹28, ₹40,000.00 per month
Benefits:
- Cell phone reimbursement
- Flexible schedule
- Internet reimbursement
- Leave encashment
- Paid sick time
- Provident Fund
Experience:
- ISO 13485: 1 year (Preferred)
Work Location: In person
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