Job Description

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:-2 to 4 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 Types: Full-time, Permanent

Pay: ₹30,000.00 - ₹40,000.00 per month

Benefits:

Cell phone reimbursement Flexible schedule Internet reimbursement Leave encashment Paid sick time Provident Fund
Experience:

Regulatory: 2 years (Preferred)
Work Location: In person