My client is a global leader in the design of complex medical device products and now seek an experienced Regulatory Affairs Officer
- Manage and ensure compliance on product registration and renewal activities of all countries where products are marketed.
- Provide regulatory advice on company's business strategy and manage projects in the provisions of these regulatory affairs services.
- Prepare and compile all necessary required application and technical documentation for Product Registration and Product License Listing
- Perform the yearly Post Market Assessment for both contact lens and lens care products as required by regulations and standards.
- Update and maintain Product Registration Profile according to the respective country regulations formats.
- Ensure regulatory compliance by completing the appropriate filings and documentation pertaining to the company's product registration/approvals
- Degree in Chemistry, Biotechnology or equivalent with 2-4 years' experience in Regulatory Affairs
- Knowledge of ISO 13485, US FDA 21 CFR Part 820 QSR and other product registration regulations
- Understanding of related Regulatory and cGMP requirements
Please send your resume in WORD format by clicking the apply button below or contact Abhik Damani on +65 6701 1527 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1544061 (Abhik Damani).