Manager, QARA Hong Kong (MedTech)

Location: Hong Kong, Hong Kong; hybrid work arrangement

Company

Johnson & Johnson MedTech develops healthcare and orthopedic solutions through its DePuy Synthes business.

What you will do

• Lead quality assurance and regulatory affairs activities for the Hong Kong market.
• Manage product registrations, renewals, variations, and full lifecycle activities for the orthopedic portfolio.
• Coordinate regulatory submissions, technical documentation, and responses to health authority inquiries.
• Monitor Hong Kong regulatory, quality, and enforcement changes and assess their impact on products and operations.
• Support regulatory inspections, quality audits, compliance assessments, and continuous improvement initiatives.
• Partner with Commercial, Operations, Supply Chain, Legal, regional leadership, and Global QARA teams to support compliant business continuity and supply.

Requirements

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline.
• 6–8 years of progressive Quality Assurance and/or Regulatory Affairs experience in medical devices, healthcare, or another regulated industry.
• Strong working knowledge of regulatory requirements applicable to Hong Kong.
• Experience managing product registrations and lifecycle activities in international markets.
• Ability to interpret regulatory and quality requirements and apply them to business and product decisions.
• English required; Cantonese and/or Mandarin preferred.

Nice to have

• Advanced degree or professional certification in Regulatory Affairs or Quality.
• Experience managing multi-market QARA portfolios and working with global regulatory frameworks.
• Experience in a multinational or matrixed organization.
• Exposure to regulatory or quality audits and health authority interactions.
• RAC or equivalent certification and experience with regulatory or quality process improvement.

Culture & Benefits

• Inclusive work environment focused on employee diversity, dignity, and individual merit.
• Limited travel, primarily regional travel related to market support activities.
• The Orthopaedics business is planned to separate into a standalone DePuy Synthes company, subject to legal, regulatory, and customary approvals.
• Employment benefits and processes may transition to DePuy Synthes following completion of the planned separation.