The posting
The Role You will plan and run medical device registrations across multiple international markets, working closely with internal teams, distributors and in-country regulatory partners. This role reports to the Regulatory Manager.
What You'll Do
- Prepare, submit and track registration dossiers across priority markets (US, EU, APAC)
- Respond to authority queries and manage approvals, renewals and licence validity
- Assess regulatory pathways and classification for new markets
- Build and maintain technical documentation (risk management, V&V, software, clinical evidence, labelling, IFU)
- Assess regulatory impact of product, software, labelling and supplier changes
- Act as the main regulatory contact for distributors and local representatives
- Support QA on post-market surveillance, adverse event reporting, audits and inspections
- Track regulatory changes, especially for software, robotics and AI-enabled devices
What You'll Need
- Degree in Biomedical Engineering, Life Sciences, Pharmacy, Engineering or related field
- 3 to 6 years of Regulatory Affairs experience in medical devices
- Hands-on experience with FDA 510(k), EU MDR and international market registrations
- Working knowledge of ISO 13485 and ISO 14971
- Able to manage multiple registrations and deadlines at once
- Strong documentation
Jessie Alayna Tan (R22109280)
EA License: 22S1193



