Executive Regulatory Affairs

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