- Act as Person Responsible and RA Manager for company to register, maintain and renew the product / establishment licenses to compliance to applicable regulatory authorities' requirements
- Manage and ensure compliance on product registration and renewal activities of all countries where company products are marketed.
- Provide regulatory advice on company's business strategy and manage projects in the provisions of these regulatory affairs services.
- Perform the yearly Post Market Assessment for both contact lens and lens care products as required by regulations and standards.
- Perform 510K pre-market notifications for products registered in relevant countries.
- Handle the specific product registration activities in EEA, Malaysia, Indonesia, Korea and new emerging markets as and when required.
- Ensure regulatory compliance by completing the appropriate filings and documentation pertaining to the company's product registration/approvals, as required by internal procedures relating to Singapore and International regulatory requirements.
- Minimum Bachelor's Degree in any science or technical field
- ISO 13485 certified. MDSAP certified
- Minimum 5 years in quality or regulatory related experience
- Minimum 3 years working experience in a medical device or GMP regulated industry
- Minimum 3 years in supervisory or management role
- Understanding of MDSAP, EU MDR 2017/745, MDD 93/42/EEC, ISO 13485 requirements and ISO 9001 requirements
- Understanding of related Regulatory and cGMP requirements
- Understanding of Product Registration, Trademark and CE Mark
- Possess strong management skills and leadership, positive attitude and good interpersonal skills
- Able to use Microsoft Office - i.e. MS Excel, MS Words & MS Powerpoint
Song Zhao Hui EA License No. 02C3423 Personnel Registration No. R1761205