QA & Regulatory Affairs Manager (Medical Devices)

About the role

The position leads regulatory affairs, quality assurance and EHS functions for medical device operations across Hong Kong and Macau. You will ensure compliance with local licences, standards and post‑market obligations while supporting commercial and technical teams.

Key responsibilities

• Maintain and renew all required local licences, permits and registrations (Radiation Board, Drug Office, EPD, EMSD, OFCA, Labour Department).
• Develop and execute regulatory strategies for pre‑market registration in Hong Kong (MDACS) and Macau (ISAF).
• Prepare, compile and submit product registration dossiers, ensuring timely approvals.
• Manage post‑market surveillance activities, including complaint handling, FSCA, adverse event reporting and product recalls.
• Ensure adherence to ISO 9001, ISO 13485 and internal QMS across both territories.
• Oversee import, storage, distribution, installation and servicing compliance, including cold‑chain management.
• Monitor quality KPIs, audit outcomes, non‑conformances and CAPA implementation.
• Lead EHS initiatives, conduct risk assessments, deliver training and manage incident investigations.

Required profile

• 5–8 years of experience in Regulatory Affairs, Quality Assurance or related functions within the medical device or highly regulated healthcare sector.
• Proven people‑management and team‑leadership experience.
• Strong knowledge of Hong Kong and Macau medical device regulations and relevant legislation.
• Deep understanding of ISO 13485, ISO 9001, ISO 14001 and ISO 45001 standards.

Required skills

• Regulatory submission preparation and filing.
• Quality Management System (QMS) implementation and maintenance.
• CAPA (Corrective and Preventive Action) management.
• Audit planning and execution.
• Post‑market surveillance (PMS) processes.
• ISO 13485, ISO 9001, ISO 14001, ISO 45001 compliance.