Manager, QARA Hong Kong

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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. 
 

• →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. 
   

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. 
 

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). 
   

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.