Description
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Job Function:
QualityJob Sub Function:
Customer/Commercial QualityJob Category:
ProfessionalAll Job Posting Locations:
Beijing, China, Hong Kong, Hong Kong, Shanghai, ChinaJob Description:
CQRA Specialist, HK
Job ID: 10020061
Location: HK, China
DePuy Synthes is recruiting for a(n) Commercial Quality and Regulatory Affairs Specialist, HK – located in HK.
Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics 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.
Job Overview
The Commercial Quality and Regulatory Affairs Specialist, HK. This role serves as the critical bridge between the company and regulatory authorities and is responsible for ensuring that all medical device products comply with local and international regulatory requirements, facilitating smooth market entry, and maintaining ongoing compliance throughout the product lifecycle. This role ensures projects are planned, executed, and delivered on time, within scope and budget, and in compliance with internal quality systems and external regulatory requirements. The position plays a critical role in supporting regulatory compliance, and on-time registration and effective post‑market surveillance in the HK market.
Key Responsibilities
- Plan, organize, and control QARA projects supporting HK commercial, operations, distributor and health authority requests, ensuring adherence to scope, timelines, budgets and quality compliance.
- Develop and maintain detailed project plans, schedules, risk registers, and communication plans; proactively manage dependencies and risks.
- Monitor and interpret regulatory policies, guidelines, and legislative updates from local (e.g., Department of Health, MDCO) and international bodies (e.g., FDA, EU MDR).
- Conduct regulatory impact assessments on new and existing product portfolios to adjust registration strategies accordingly.
- Prepare, review, and submit comprehensive registration dossiers and technical files for medical device approvals, renewals, and variations.
- Oversee post-market regulatory obligations, including adverse event reporting, periodic safety updates, and annual compliance reports.
- Manage change control processes for product design, manufacturing site changes, or labeling updates, determining the appropriate regulatory pathway (notification vs. new submission).
- Maintain accurate and up-to-date regulatory records, certificates, and license databases.
- Coordinated process optimization within CQRA HK organization and support commercial projects with cross-functional department as CQRA expert.
- Support internal audits, external audits, and health authority inspections related to complaints and post‑market activities in HK.
- Contribute to continuous improvement initiatives to enhance complaint handling efficiency and compliance.
Qualifications
Education:
- Bachelor’s degree in Quality, Engineering, Life Sciences, Regulatory Affairs, or a related discipline (required).
- Advanced degree in a scientific or regulatory field (preferred).
Experience and Skills:
Required:
- Typically 0-2 years of experience in Quality, Regulatory, or Compliance roles within a regulated industry.
- Experience supporting registration, complaint handling, product event reporting, or post‑market surveillance activities.
- Foundational understanding of quality system requirements and regulatory expectations for commercial operations.
- Ability to interpret procedures and regulatory requirements and apply them accurately.
Preferred:
- Experience in medical devices, healthcare, or other highly regulated industries.
- Familiarity with HK regulatory and vigilance requirements
- Experience supporting audits, inspections, or health authority interactions.
- Experience working in a multinational or matrixed organization.
- Quality or Regulatory certifications (e.g., RAC).
- Strong attention to detail, documentation, and data accuracy.
- Effective communication and cross‑functional collaboration skills.
Other:
- Language: Cantonese/Mandarin required; English proficiency preferred.
- Travel: Limited; occasional domestic travel within China.
- Certifications: Quality or Regulatory certifications preferred but not required.
Required Skills:
Preferred Skills:
Business Behavior, Compliance Management, Continuous Improvement, Data Analysis, Data Compilation, Detail-Oriented, Execution Focus, Goal Attainment, Internal Controls, Issue Escalation, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing