Regulatory Affairs Specialist

• Prepare and support regulatory submissions of medical devices to health authorities, including assisting local partners
• Monitor and implement new or updated regulations impacting product registration and ensure regulatory databases are current
• Support internal teams (Sales, Operations, R&D) with regulatory guidance, maintain product registration processes, and participate in quality audits
• Manage medical device licenses, handle Field Service Notices with authorities, and ensure relevant standards are maintained and updated

• Degree in engineering or life sciences preferred
• other relevant degrees will be considered
• Demonstrated interest in regulatory affairs and quality management, with experience in APAC regulations being an added advantage
• Strong multitasking skills and ability to manage several projects simultaneously

Experience in APAC regulations

Excellent employee compensation and benefits