Manager, QARA Hong Kong

About the role

The Manager, QARA Hong Kong provides operational leadership for quality assurance and regulatory affairs supporting the Hong Kong market for DePuy Synthes, a Johnson & Johnson orthopaedics business.

Key responsibilities

• Lead Quality Assurance and Regulatory Affairs activities for product registrations, renewals, variations and lifecycle management in Hong Kong.
• Ensure compliance with Hong Kong regulatory requirements, internal policies, international standards and DePuy Synthes QMS.
• Serve as the primary QARA contact for local market support and coordinate submissions and health authority responses.
• Partner with Commercial, Operations, Supply Chain, Legal and Global QARA teams to maintain supply continuity and business objectives.
• Monitor regulatory and quality changes, support inspections and audits, and drive continuous improvement initiatives.

Required profile

• 6–8 years progressive experience in Quality Assurance and/or Regulatory Affairs within medical devices or regulated healthcare.
• Strong knowledge of Hong Kong regulatory requirements and experience managing international product registrations.
• Excellent stakeholder management, communication and ability to work in a matrixed, fast‑paced environment.
• Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering or related field; advanced degree or certification preferred.

Required skills

• Regulatory submissions and product registration processes.
• Quality management system implementation and audit support.
• Medical device regulatory frameworks (e.g., RAC certification).