QARA Manager – Hong Kong

About the role

The Manager, QARA Hong Kong provides operational leadership for quality assurance and regulatory affairs supporting the Hong Kong market. This role ensures regulatory compliance, effective quality system execution, and sustained market access for DePuy Synthes’ orthopaedics portfolio.

Key responsibilities

• Lead and manage Quality Assurance and Regulatory Affairs activities for product registrations, renewals, variations and full lifecycle management in Hong Kong.
• Ensure compliance with Hong Kong regulatory requirements, internal policies, international standards and DePuy Synthes quality management system expectations.
• Serve as the primary QARA contact for the Hong Kong market, coordinating submissions and responding to health authority inquiries.
• Partner with cross‑functional teams (Commercial, Operations, Supply Chain, Legal, Global QARA) to support business objectives and supply continuity.
• Monitor regulatory, quality and enforcement changes and assess their impact on products and operations.
• Support regulatory inspections, quality audits and compliance assessments as required.

Required profile

• 6–8 years progressive experience in Quality Assurance and/or Regulatory Affairs within medical devices or other regulated industries.
• Strong knowledge of Hong Kong regulatory requirements and experience managing product registrations and lifecycle activities.
• Ability to interpret and apply regulatory and quality requirements to support business decisions.
• Excellent stakeholder management, communication and cross‑functional collaboration skills.
• Ability to manage multiple priorities in a fast‑paced, matrixed environment.

Required skills

• Regulatory affairs expertise for the Hong Kong market.
• Quality management system implementation.
• Regulatory submission preparation and technical documentation.
• English proficiency; Cantonese and/or Mandarin preferred.
• RAC or equivalent certification preferred.