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 for DePuy Synthes’ orthopedics portfolio. The role ensures regulatory compliance, effective quality‑management‑system execution, and sustained market access in a highly regulated environment.

Key responsibilities

• Lead and manage QA and regulatory activities for product registrations, renewals, variations and full lifecycle management in Hong Kong.
• Ensure compliance with Hong Kong regulatory requirements, internal policies, applicable international standards and the company’s QMS.
• Serve as the primary QARA contact for the Hong Kong market and coordinate submissions, technical documentation and health‑authority responses.
• Partner with Commercial, Operations, Supply Chain, Legal and Global QARA teams to support business objectives and supply continuity.
• Monitor regulatory, quality and enforcement changes and assess their impact on products, portfolios and operations.
• Support and participate in regulatory inspections, quality audits and compliance assessments.
• Contribute to continuous‑improvement initiatives to enhance QARA efficiency, compliance consistency and inspection readiness.

Required profile

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering or a related discipline.
• Experience in regulatory affairs and quality assurance within the medical‑device or orthopedics sector.
• Knowledge of Hong Kong regulatory requirements and relevant international standards.
• Ability to work with cross‑functional teams and manage multiple projects.

Required skills

• Regulatory affairs
• Quality assurance
• Product registration and lifecycle management
• Technical documentation preparation
• Regulatory submission coordination