Commercial Quality & Regulatory Affairs Specialist – Hong Kong

About the role

The Commercial Quality and Regulatory Affairs (CQRA) Specialist will act as the key liaison between DePuy Synthes and Hong Kong health authorities. The role ensures that all medical device products meet local and international regulatory standards, supporting market entry and ongoing compliance throughout the product lifecycle.

Key responsibilities

• Plan, organize, and control QARA projects supporting Hong Kong commercial, operations, distributor and health‑authority requests, ensuring adherence to scope, timelines, budgets and quality compliance.
• Develop and maintain detailed project plans, risk assessments, and documentation to meet local and international regulatory requirements.
• Coordinate submissions and communications with Hong Kong health authorities, ensuring timely market entry and post‑market surveillance.
• Collaborate with cross‑functional teams including R&D, manufacturing, and supply chain to ensure product compliance throughout the lifecycle.
• Monitor changes in regulations and standards, updating internal processes and providing guidance to stakeholders.

Required profile

• Relevant degree in life sciences, engineering, or a related field.
• Experience in regulatory affairs or quality assurance for medical devices, preferably in the Hong Kong market.
• Strong understanding of local and international medical device regulations (e.g., HK Medical Device Administrative Control System, ISO 13485, MDR).
• Excellent project management and communication skills.

Required skills

• Regulatory submission preparation
• Quality management systems implementation
• Project planning and risk management