Regulatory Affairs Executive

Responsibilities:

1. Assisting in maintenance of the company’s Regulatory Affairs and applicable Jurisdiction Medical Device registration and registration maintenance.

2. Assisting in maintaining regulatory documents in good order.

3. Reviewing and updating external document master list, keeping up to date with changes in Regulatory Legislation and Guidelines

4. Gathering and updating Regulatory Registration Master List periodically to reflect up to date product status and regulatory information.

5. Preparing document for License and Regulatory Registration submissions and renewals on a timely manner.

6. Collecting and coordinating information and preparing regulatory documentations for submission to Regulatory Authorities or to commercial partners.

7. Collecting and coordinating information and preparing regulatory documentations for endorsement.

8. Contacting and arranging endorsement of regulatory certificates and licenses obtained from the authority

9. Assisting in identify incidents/ issues which requires advisory notice/ filed safety notice/ filed safety corrective action.

10. Assisting in reporting and vigilance activities.

11. Distributing User Feedback Questionnaires to customers and following up in a timely manner.

12. Distributing User Feedback Questionnaires to customers and following up in a timely manner.

13. Gathering and analyzing User Feedback data and preparing User Feedback Analysis report.

14. Assisting in the preparation for Regulatory Audit.

15. Participating in Internal Audits, Supplier/ OM’s period evaluation audit and External Audit.

16. Participating in Risk Management Team.

17. Performing other work related functions as assigned by superior

Requirements:

· At least Diploma/ Degree in Engineering/ Biology/ Chemistry or any related.

· Min 1 year of working experience in related field.

· Must be able to work in Bandar Tasik Selatan area.

· Ability to work in team work and independently.