International Regulatory Specialist

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