Responsible for maintaining registration of medical device products in Singapore, Malaysia, and Emerging Markets (Myanmar, SriLanka, Bangladesh, Cambodia, Laos, Brunei, Nepal, Maldives, Bhutan, and EastTimor Market)
Plan, prepare, and manage regulatory submissions and change notifications
Ensure ongoing compliance with local and international regulatory requirements (e.g., HSA, MDA, FDA, EU MDR/IVDR, ISO standards)
Manage distributor registration matters, local labelling, and regulatory reporting
Maintain regulatory database and report regularly
Track regulatory compliance and research regulatory‑related information and updates
Quality Assurance (QA)
Maintain and improve the Quality Management System (QMS) in accordance with applicable standards (e.g., GDP‑MMD, GDP)
Ensure compliance with procedures, work instructions, and quality rec...