Work Location: Joo Seng Rd
5 Days Work - Week
- To maintain and renew the product / establishment licenses to compliance to applicable regulatory authorities’ requirements
- To manage and ensure compliance on product registration and renewal activities of all countries where products are marketed.
- To provide regulatory advice on company’s business strategy and manage projects in the provisions of these regulatory affairs services.
- To perform the yearly Post Market Assessment for products as required by regulations and standards.
- To handle the specific product registration activities in EEA, Malaysia, Indonesia, Korea and new emerging markets as and when required.
- To 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.
- Bachelors Degree in any science or technical field
- ISO 13485 certified | MDSAP certified
- Minimum 5 years in quality or regulatory related experience
- Experience in a medical device or GMP regulated industry
- Understanding of related Regulatory and cGMP requirements
- Understanding of Product Registration, Trademark and CE Mark
- Able to use Microsoft Office - i.e. MS Excel, MS Words & MS Powerpoint
- Results-oriented, meticulous and a self-motivated team player
- Effective decision making capabilities
*Only shortlisted candidates will be notified.
How to apply:
Please forward your resume in MS WORD FORMAT to email@example.com
EA Personnel: Shiela Joseph
EA Reg ID: R1986902
EA License No: 01C3135