Description
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:
Non-StandardJob Sub Function:
Fixed Term EmployeeJob Category:
Non-StandardAll Job Posting Locations:
Mongkok, Kowloon, Hong KongJob Description:
Job Description
Hong Kong Regulatory Affairs Contractor (1-Year) – Project Osprey
Contract Duration: 12 months
Role Purpose
This role is responsible for providing dedicated Regulatory Affairs support for DPS separation (Project Osprey) activities in Hong Kong. The contractor will manage regulatory related responsibilities, licenses transfer, tender support, new registration under new legal entity and authority interactions to ensure business continuity during the transition to a new legal entity.
Key Responsibilities
Prepare and submit DPS license transfer applications, supporting documents, and declarations related to legal entity separation.
Execute regulatory activities related to DPS separation, ensuring uninterrupted regulatory compliance and market supply.
Responsible for DPS tenders by providing the documents for hospital quotation and tenders
Prepare and submit new applications under the new legal entity for DBX® Demineralized Bone Matrix regulated under the Human Organ Transplant Ordinance.
Prepare and submit new applications for Medical Radio Frequency Equipment regulated by the Office of the Communications Authority (OFCA).
Act as the primary contact for Project Osprey and attend Osprey related meetings
Maintain regulatory databases, records, and submission trackers in Hong Kong RA database
Attend Osprey‑related project meetings and provide regulatory updates, risk assessments, and status reporting.
Coordinate regulatory inputs across cross‑functional teams to support overall project milestones.
Collaborate cross-functionally with Quality, Supply Chain, and Commercial teams to support DPS separation activities.
Maintain database in MDRIM for HK and Macau
Qualifications & Experience
- Bachelor’s degree in Life Sciences, Pharmacy, Biomedical Engineering, or related discipline.
- 3–5 years of Regulatory Affairs experience, preferably in medical devices in Hong Kong.
- Experience with legal entity changes, license transfers, or business separation projects is preferred.
- Familiarity with Hong Kong regulatory authorities
Key Skills & Competencies
- Strong regulatory execution and attention to detail.
- Excellent analytical, problem-solving, and organizational skills.
- Clear business writing and regulatory communication capability.
- Ability to manage multiple submissions under tight timelines.
- High level of professionalism, confidentiality, and accountability.
Required Skills:
Preferred Skills:
