Manager, QARA Hong Kong

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Job Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Affairs

Job Category:
People Leader

All Job Posting Locations:
Hong Kong, Hong Kong, Mongkok, Hong Kong, Hong Kong

Job Description:

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...