Manager, QARA

Johnson & Johnson

Manager, QARA overseeing quality assurance and regulatory affairs for DePuy Synthes’ products in the Hong Kong market. Responsible for ensuring compliance and effective management systems in a regulated environment.

Posted 7/18/2026full-timeMongkok • 🇭🇰 Hong KongMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory Affairs and Quality Assurance, with a strong focus on compliance and risk management in the Hong Kong market. Proven ability to lead product registrations and lifecycle management while ensuring effective stakeholder collaboration.

Highest-signal resume keywords

Regulatory ComplianceQuality Management System ExecutionProduct Registration ManagementStakeholder ManagementRegulatory Affairs Expertise

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Requirements KnowledgeQuality AssuranceLifecycle ManagementRegulatory SubmissionsRisk ManagementRegulatory InspectionsQuality AuditsCompliance Assessments

Soft Skills

Communication SkillsCross-Functional CollaborationStakeholder EngagementPriority Management

Certifications & Qualifications

RAC

Industry Keywords

Medical DeviceHealthcareRegulated IndustriesHong Kong Market

About the role

Key responsibilities & impact

Provide operational leadership for quality assurance and regulatory affairs supporting the Hong Kong market
Ensure regulatory compliance and effective quality management system execution
Safeguard patient safety and manage quality and regulatory risk
Partner with local market stakeholders, regional leadership, and Global QARA teams
Lead and manage QARA activities for product registrations and lifecycle management
Coordinate regulatory submissions and responses to health authority inquiries
Monitor regulatory, quality, and enforcement changes applicable to Hong Kong
Support regulatory inspections, quality audits, and compliance assessments

Requirements

What you’ll need

Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline
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
English required; Cantonese and/or Mandarin preferred
RAC or equivalent preferred but not required

Benefits

Comp & perks

Inclusive work environment
Health is everything
Opportunities for professional development