Regulatory Affairs Officer Project Osprey Contractor

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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 Ospreyrelated project meetings and provide regulatory updates risk assessments and status reporting.

• Coordinate regulatory inputs across crossfunctional 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

• Bachelors degree in Life Sciences Pharmacy Biomedical Engineering or related discipline.
• 35 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.

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