Regulatory Affairs and Quality Specialist
5 days ago
Regulatory Affairs and Quality Specialist Join to apply for the Regulatory Affairs and Quality Specialist role at Links International . Our client is a global leader in medical technology, committed to delivering safe and effective solutions that improve patient outcomes. They are expanding their Hong Kong team and seeking a Regulatory & Quality Compliance Specialist to strengthen compliance and quality assurance for their service center operations. Role Overview The successful candidate will be responsible for implementing and maintaining quality compliance and assurance activities, ensuring adherence to Hong Kong regulatory requirements and global standards. Key Responsibilities Establish and maintain distributor and importer quality systems in line with Hong Kong Code of Practice. Ensure proper control measures for ordering, supply, and distribution of medical devices. Apply for and maintain licenses and permits (Wholesale Dealer Licence, Dangerous Goods, Psychotropic Drugs). Support audits and inspections, implement corrective actions, and ensure HK GDP compliance. Monitor legislative updates (CAP 134, CAP 138, CAP 137) and update SOPs/WIs accordingly. Manage nonconformance, CAPA plans, and effectiveness checks. Oversee document control, electronic records, and SAP quality notifications. Conduct internal and external audits, including third‑party distributors. Organize quality training and maintain regulatory reference libraries. Qualifications Bachelor’s degree in Pharmacy (Hong Kong) or equivalent science disciplines Minimum 3 years’ experience in Quality Assurance within pharmaceuticals or medical devices Experience with ISO 9001, ISO 13485, and/or GDP standards Hong Kong Registered Pharmacist highly preferred Strong analytical, problem‑solving, and communication skills; fluent in English and Cantonese/Mandarin Why Join Us? Be part of a global healthcare leader committed to quality and patient safety. Drive compliance excellence and make a tangible impact on healthcare delivery. Enjoy a collaborative culture with clear career progression opportunities. Ready to Make an Impact? Apply now or send your latest CV to for a confidential discussion about this exciting opportunity in Hong Kong’s healthcare market. Additional Details Seniority level: Entry level Employment type: Full‑time Job function: Quality Assurance Industries: Medical Equipment Manufacturing #J-18808-Ljbffr
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Global Regulatory
5 days ago
Hong Kong Island, Hong Kong SAR China Links International Full timeA global healthcare leader in Hong Kong is seeking a Regulatory Affairs and Quality Specialist to enhance quality compliance for their service center operations. The successful candidate will implement and maintain quality assurance and ensure adherence to Hong Kong regulations and global standards. This role requires a Bachelor’s degree in Pharmacy, at...
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Senior Specialist, Regulatory Affairs
2 days ago
hong kong, Hong Kong SAR China Teva Pharmaceuticals Full timeJoin to apply for the Senior Regulatory Affairs Specialist role at Teva Pharmaceuticals 2 days ago Be among the first 25 applicants Join to apply for the Senior Regulatory Affairs Specialist role at Teva Pharmaceuticals Get AI-powered advice on this job and more exclusive features. Who We AreTogether, we’re on a mission to make good health more affordable...
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Regulatory Affairs and Quality Specialist
5 days ago
Hong Kong Island, Hong Kong SAR China Trades Workforce Solutions Full timeOur client is a global leader in medical technology, committed to delivering safe and effective solutions that improve patient outcomes. They are expanding their Hong Kong team and seeking a Regulatory & Quality Compliance Specialist to strengthen compliance and quality assurance for their service center operations. Role Overview The successful candidate...
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Assistant Regulatory Affairs
7 days ago
Hong Kong Island, Hong Kong SAR China Chemill Pharma Ltd. Full timeAssistant Regulatory Affairs & Quality Assurance Manager The Assistant Regulatory Affairs & Quality Assurance Manager will play a key role in managing all regulatory activities related to the registration, approval, and lifecycle maintenance of products in the Hong King market. This position requires close collaboration with global manufacturers, internal...
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Regulatory Affairs
5 days ago
Hong Kong Island, Hong Kong SAR China Michael Page International (HK) Ltd Full timeRegulatory Affairs / QA Specialist, Medical Device Innovate in next‑generation surgical robotics. Join a fast‑growing medtech pioneer. Our client is a fast‑growing, Hong Kong‑based technology company specializing in precision robotics. With a strong focus on innovation, they develop advanced hardware solutions for medical and industrial applications....
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Regulatory Affairs
2 weeks ago
Hong Kong Island, Hong Kong SAR China Projob21.com Ltd. Full timeRegulatory Affairs & Central Compliance Senior Manager Oversight Regulatory Affairs & Central Compliance Excellent job security and worklife balance Our Client Searching for Regulatory Central Compliance Senior Manager with one of the most established Global Private Bank with 250 employees+ in North Asia Branch and operations in over 20 locations. Job Duties...
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Associate Director, Regulatory Affairs
2 days ago
Hong Kong Island, Hong Kong SAR China Michael Page International (HK) Ltd Full timeAssociate Director, Regulatory Affairs - Biotech Looking for an experienced Associate Director, Regulatory Affairs to lead regulatory strategies and submissions for cutting-edge biotech products. This role offers high visibility and the opportunity to shape regulatory pathways in a dynamic, fast-growing organization. Our client is a leading biotech company...
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Hong Kong Island, Hong Kong SAR China Trades Workforce Solutions Full timeA global medical technology leader is expanding its Hong Kong team and seeking a Regulatory & Quality Compliance Specialist to enhance compliance and quality assurance operations. The successful candidate will implement activities to ensure adherence to local regulatory requirements, manage quality systems, and oversee audits. Candidates should have a...
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Regulatory Affairs Partner
2 weeks ago
Hong Kong Island, Hong Kong SAR China F. Hoffmann-La Roche Gruppe Full timeAt Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure...
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Regulatory Affairs
7 days ago
Hong Kong Island, Hong Kong SAR China Chemill Pharma Ltd. Full timeA pharmaceutical company in Hong Kong seeks an Assistant Regulatory Affairs & Quality Assurance Manager. The role includes managing regulatory activities for product approvals and compliance. Candidates should have 3-5 years of regulatory experience, strong coordination, and communication skills in English and Cantonese. This full-time position offers...