HK QARA Manager: Quality & Regulatory Leadership

Brighter Signals; Hong Kong; On-site; HKD 900,000 - 1,300,000; Full time

Job summary

Johnson & Johnson in Hong Kong seeks a Manager, QARA to lead quality assurance and regulatory affairs for the Hong Kong market. You will drive registrations, renewals, variations and lifecycle activities, ensuring compliance with local laws and global standards to safeguard patient safety and market access.

The role requires 6–8 years in QA/RA, strong HK regulatory knowledge, and effective cross‑functional collaboration with Global QARA, Commercial, Operations, and Legal teams to support

Qualifications

• 6–8 years of progressive experience in Quality Assurance and/or Regulatory Affairs within medical devices, 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.

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.

Skills

Stakeholder management

Cross-functional collaboration

Regulatory affairs knowledge

Quality assurance

Project management

Education

Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or related

Advanced degree or professional certification in Regulatory Affairs, Quality, or related field

Job description

Johnson & Johnson in Hong Kong seeks a Manager, QARA to lead quality assurance and regulatory affairs for the Hong Kong market. You will drive registrations, renewals, variations and lifecycle activities, ensuring compliance with local laws and global standards to safeguard patient safety and market access.

The role requires 6–8 years in QA/RA, strong HK regulatory knowledge, and effective cross‑functional collaboration with Global QARA, Commercial, Operations, and Legal teams to support