Sr. Regulatory Officer

Role & responsibilities

1. Maintain regulatory files. Maintain and update regulatory authorizations, such as euMDR, 510(k), UCKA PPE & medical device licenses. etc. Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes, and Support approval in other regions as required.

2. Ensure the Quality Management System complies with the Drugs and Cosmetics Act, Medical Device Rule 2017 & Medical Device Regulations, and is effectively established, maintained, and efficient.

3.Manage internal and external audits, inspection readiness, and Regulatory Authority inspections.

4. Ensuring personal and company compliance with local regulations, policies, and procedures.

5. Managing the complete PMS (post-market surveillance) process.

6. Managed product and process risk management, clinical evaluation, product verification, and validation.

7. Provide training to concerned employees related to ISO, MDR, GMP, and Medical device regulations as per EU and assessment.

8. Assess device-related incidents/complaints for medical device reporting requirements. Compile and submit reportable events to relevant regulatory authorities on time. Handle recalls and field actions, if required.

9. Review and approve translations of product labeling (e.g., labels, IFU, user manual) and promotional material (external and internal communication).

10. Understand local labeling requirements and ensure all activities related to product labeling are performed correctly.

11. Ensure compliance with Environmental regulations.