Senior RAQA Specialist

Summary of the Role

Regulatory Affairs (RA)

• Responsible for maintaining registration of medical device products in Singapore, Malaysia, and Emerging Markets
• 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)
• Distributor management in terms of registration matters, local labelling, and regulatory reporting
• Maintain regulatory database and report regularly
• Keep track and ensure regulatory compliance and research on regulatory-related information/ updates

Quality Assurance (QA)

• Maintain and improve the Quality Management System (QMS) in accordance with applicable standards (e.g., GPDMD, GDP)
• Ensure compliance with procedures, work instructions, and quality records
• Support and/or lead internal audits, supplie...