Senior RAQA Specialist

Key Responsibilities

• Regulatory Affairs (RA)
  • 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...