Manager – Quality Assurance and Regulatory Affairs

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Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

People Leader

All Job Posting Locations:

Hong Kong, Hong Kong, Mongkok, Hong Kong, Hong Kong

Job Description:

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 cross‑functional 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: Bachelor’s 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: 

• 6–8 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 cross‑functional collaboration skills. 
• Ability to manage multiple priorities in a complex, fast‑paced, and matrixed environment. 
   

Preferred: 

• Experience multi‑market 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. 

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. 

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 plans. In 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.​

Required Skills:

Preferred Skills:

Business Writing, Compliance Risk, Developing Others, Fact-Based Decision Making, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Legal Support, Operations Management, Policy Development, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Strategic Thinking, Team Management