Manager, QARA Hong Kong

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DePuy Synthes is recruiting for a Manager QARA Hong Kong

The Manager QARA Hong Kong provides operational leadership for quality assurance and regulatory affairs supporting the Hong Kong market. This role is accountable for ensuring regulatory compliance effective quality management system execution and sustained market access for DePuy Synthes Orthopedics portfolio in a highly regulated environment.

This role plays a critical part in safeguarding patient safety managing quality and regulatory risk and enabling compliant business continuity and growth. The Manager partners closely with local market stakeholders regional leadership and Global QARA teams to support product lifecycle activities and operational excellence.

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 in collaboration with Global QARA teams.
• Partner with crossfunctional teams including Commercial Operations Supply Chain Legal and Global QARA to support business objectives and supply continuity.
• Monitor regulatory quality and enforcement changes applicable to Hong Kong and assess potential impacts to products portfolios and operations.
• Support and participate in regulatory inspections quality audits and compliance assessments as required.
• Contribute to continuous improvement initiatives to enhance QARA efficiency compliance consistency and inspection readiness.
  

Qualifications

Education

Required: Bachelors degree in Regulatory Affairs Life Sciences Engineering or a related discipline.

Preferred: Advanced degree or professional certification in Regulatory Affairs Quality or a related field.

Experience and Skills

Required:

• 68 years of progressive experience in Quality Assurance and/or Regulatory Affairs within the medical device healthcare or other regulated industries.
• Strong working knowledge of regulatory requirements applicable to Hong Kong.
• Experience managing product registrations and lifecycle activities in international markets.
• Ability to interpret and apply regulatory and quality requirements to support business and product decisions.
• Strong stakeholder management communication and crossfunctional collaboration skills.
• Ability to manage multiple priorities in a complex fastpaced and matrixed environment.
  

Preferred:

• Experience multimarket QARA portfolios.
• Familiarity with global regulatory frameworks and harmonization initiatives.
• Experience working in a multinational or matrixed organization.
• Exposure to regulatory audits quality audits or health authority interactions.
• Demonstrated experience contributing to regulatory or quality process improvement initiatives.
• Regulatory Affairs or Quality certification (e.g. RAC or equivalent).
  

Other

Language: English required; Cantonese and/or Mandarin preferred.

Travel: Limited; primarily regional travel related to market support activities.

Certifications: RAC or equivalent preferred but not required.

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Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months subject to legal requirements including consultation with works councils and other employee representative bodies as may be required regulatory approvals and other customary conditions and approvals. Should you accept this position it is anticipated that following conclusion of the transaction you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes programs policies and benefit that case details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

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