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Manager, QARA
Johnson & JohnsonManager, QARA providing operational leadership for quality assurance and regulatory affairs at DePuy Synthes. Ensuring compliance and managing product lifecycle activities for the Hong Kong market.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Assurance and Regulatory Affairs, with a strong focus on regulatory compliance and quality management systems specific to the Hong Kong market. Proven ability to lead product registrations and lifecycle activities while effectively collaborating with stakeholders across various functions.
Highest-signal resume keywords
Regulatory ComplianceQuality Management SystemsProduct RegistrationsStakeholder ManagementRegulatory Affairs Certification
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Quality AssuranceRegulatory AffairsRegulatory RequirementsProduct Lifecycle ManagementMedical Device RegulationsHealthcare ComplianceData InterpretationRisk Assessment
Soft Skills
CommunicationCross-Functional CollaborationStakeholder EngagementPrioritizationAdaptability
Certifications & Qualifications
Regulatory Affairs CertificationQuality Certification
Industry Keywords
Medical DeviceHealthcareRegulated IndustriesHong Kong MarketQuality Management
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.
- Partner with local market stakeholders, regional leadership, and Global QARA teams to support product lifecycle activities.
- Lead and manage Quality Assurance and Regulatory Affairs activities to support product registrations and renewals.
- Monitor regulatory, quality, and enforcement changes applicable to Hong Kong and assess potential impacts to products.
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.
- Regulatory Affairs or Quality certification (e.g., RAC or equivalent).
Benefits
Comp & perks- Health insurance
- 401(k) matching
- Flexible working hours
- Paid time off
- Professional development opportunities