Manager, QARA Hong Kong

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工作职能：Regulatory Affairs Group

作业子功能：Regulatory Affairs

职位类别：People Leader

所有职位发布位置：Hong Kong, Hong Kong, Mongkok, Hong Kong, Hong Kong

职位描述：
DePuy Synthes is recruiting for a Manager, QARA Hong Kong

The Manager, QARA Hong Kong provides operational leadership for quality assurance and regulatory affairs supporting the Hong Kong market. This role is accountable for ensuring regulatory compliance, effective quality management system execution, and sustained market access for DePuy Synthes’ Orthopedics portfolio in a highly regulated environment.

This role plays a critical part in safeguarding patient safety, managing quality and regulatory risk, and enabling compliant business continuity and growth. The Manager partners closely with local market stakeholders, regional leadership, and Global QARA teams to support product lifecycle activities and operational excellence.

Key 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.

Qualifications

Education

Required: Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline.

Preferred: Advanced degree or professional certification in Regulatory Affairs, Quality, or a related field.

Experience and Skills

Required:

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.

Preferred:

Experience multi‑market QARA portfolios.

Familiarity with global regulatory frameworks and harmonization initiatives.

Experience working in a multinational or matrixed organization.

Exposure to regulatory audits, quality audits, or health authority interactions.

Demonstrated experience contributing to regulatory or quality process improvement initiatives.

Regulatory Affairs or Quality certification (e.g., RAC or equivalent).

Other

Language: English required; Cantonese and/or Mandarin preferred.

Travel: Limited; primarily regional travel related to market support activities.

Certifications: RAC or equivalent preferred but not required.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.​

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

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Required Skills:

Preferred Skills:
包容性领导力, 产品授权, 创新, 法规遵从, 法律支持, 风险规范, 公共政策, 基于事实的决策制定, 监管环境, 监管开发, 监管事务管理, 领导力, 培养他人, 商务写作, 团队管理, 行业分析, 运营管理, 战略性思维, 政策开发