QARA Manager

Johnson & Johnson

Manager, QARA providing operational leadership for regulatory affairs in Hong Kong market for DePuy Synthes. Ensuring compliance and quality management in a highly regulated environment.

Posted 5/26/2026full-timeMongkok • 🇭🇰 Hong KongMid-LevelSeniorWebsite

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
Lead Quality Assurance and Regulatory Affairs activities to support product registrations, renewals, variations, and lifecycle management
Partner with cross‑functional teams including Commercial, Operations, Supply Chain, Legal, and Global QARA

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
Regulatory Affairs or Quality certification (e.g., RAC or equivalent)
English required; Cantonese and/or Mandarin preferred

Benefits

Comp & perks

Inclusive work environment
Opportunities for professional development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

quality assuranceregulatory affairsregulatory compliancequality management systemproduct registrationslifecycle managementregulatory requirementsinternational markets

Soft Skills

operational leadershipcross-functional collaboration

Certifications

RAC