Executive Regulatory Affairs

6 hours ago

Navi Mumbai, Maharashtra, India METSL Full time ₹ 3,00,000 - ₹ 4,00,000 per year

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, ₹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

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