Manager, QARA Hong Kong

About the role

DePuy Synthes is recruiting a Manager, QARA Hong Kong. The role provides operational leadership for quality assurance and regulatory affairs supporting the Hong Kong market, ensuring regulatory compliance, effective quality management system execution and sustained market access for the Orthopedics portfolio in a highly regulated environment. It is accountable for safeguarding patient safety, managing quality and regulatory risk and enabling compliant business continuity and growth.

Key responsibilities

• Lead and manage Quality Assurance and Regulatory Affairs activities to support product registrations, renewals, variations and full lifecycle management for the Hong Kong market.
• Ensure compliance with Hong Kong regulatory requirements, internal policies, applicable international standards and DePuy Synthes quality management system expectations.
• Serve as the primary QARA point of contact for Hong Kong Local Market Support.
• Coordinate regulatory submissions, technical documentation and responses to health authority inquiries with Global QARA teams.
• Partner with Commercial, Operations, Supply Chain, Legal and Global QARA teams to support business objectives and supply continuity.
• Monitor regulatory, quality and enforcement changes in Hong Kong and assess their impact on products, portfolios and operations.
• Support and take part in regulatory inspections, quality audits and compliance assessments as required.
• Contribute to continuous improvement initiatives to improve QARA efficiency, compliance consistency and inspection readiness.

Required profile

• Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering or a related discipline; advanced degree or professional certification preferred.
• 6-8 years of progressive experience in Quality Assurance and/or Regulatory Affairs in medical device, healthcare or other regulated industries.
• Experience managing product registrations and lifecycle activities in international markets.
• English required; Cantonese and/or Mandarin preferred.
• Limited travel, mainly regional, related to market support activities.

Required skills

• Strong working knowledge of Hong Kong regulatory requirements.
• Experience interpreting and applying regulatory and quality requirements to support business and product decisions.
• Stakeholder management, communication and cross-functional collaboration skills.
• Ability to manage multiple priorities in a complex, fast-paced, matrixed environment.
• Preferred: multi-market QARA portfolio experience, familiarity with global regulatory frameworks, exposure to regulatory or quality audits, and RAC or equivalent certification.