CQRA Specialist, HK

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Customer/Commercial Quality Job Category: Professional All Job Posting Locations: Beijing, China, Hong Kong, Hong Kong, Shanghai, China Job 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.

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.

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.