Regulatory Affairs (RA) Executive (Manufacturing based in Kuala Lumpur)

Job Description

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 in 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 documents with the Regulatory Agency.
9. Assisting in reviewing the related product registration certificates and licenses obtained from the authority.
10. Assisting in identifying incidents/issues which require advisory notice/field safety notice/field safety corrective action.
11. Assisting in reporting and vigilance activities.
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 periodic evaluation audit, and External Audit.
16. Participating in Risk Management Team.
17. Performing other work-related functions as assigned by superior.

Requirements

1. Minimum a Diploma in any field.
2. At least 2 years of RA experience from any industry.
3. Candidate from manufacturing industry are added advantage.
4. Good in English (Spoken & Written).
5. Working hour: Mon-Fri (9am-5.30pm)