Regulatory Affairs
5 days ago
Regulatory 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. The team is made up of top‑tier engineers and researchers, and the company offers a dynamic, collaborative environment where cutting‑edge ideas are turned into impactful products. Responsibilities Oversee quality systems and regulatory compliance across sites Maintain certifications (ISO 13485, CE, FDA 510(k), NMPA) Lead audits, internal training, and documentation Manage supplier quality and customer‑related issues Support regulatory submissions and product validations Report quality performance to senior management Guide and mentor QA team members Qualifications Degree in science, engineering, or a related field 8+ years of experience, with 3+ in QA management (medical device preferred) Strong knowledge of ISO 13485, FDA, CE, NMPA Excellent leadership, communication, and problem‑solving skills Fluent in English, Cantonese, and Mandarin Willing to travel as needed Benefits 5‑day work week 14 days annual leave Performance bonus Medical insurance (family members covered) Work from home #J-18808-Ljbffr
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Associate Director, Regulatory Affairs
1 day 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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Regulatory Affairs Partner
2 weeks ago
Hong Kong Island, Hong Kong SAR China F. Hoffmann-La Roche Gruppe Full timeA leading global healthcare company in Hong Kong is seeking a Regulatory Affairs Partner to drive regulatory strategies and ensure compliance for their products. With over 5 years of regulatory affairs experience in Hong Kong, the ideal candidate will work across functions to navigate the evolving regulatory landscape and accelerate patient access to...
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Senior Specialist, Regulatory Affairs
1 day 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 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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Associate Director, Regulatory Affairs
1 day ago
Hong Kong Island, Hong Kong SAR China Michael Page International (Hong Kong) Limited Full timeLead Regulatory Strategy For Innovative Biotech Products Drive Regional Regulatory Submissions About Our Client Our client is a leading biotech company specializing in innovative therapies that improve patient outcomes. With a team of around 150 professionals primarily based in China and a lean, agile structure in Hong Kong, they are committed to advancing...
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Regulatory Affairs and Quality Specialist
5 days ago
Hong Kong Island, Hong Kong SAR China Links International Full timeRegulatory 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...
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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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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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Biotech Regulatory Affairs Lead – Asia
1 day ago
Hong Kong Island, Hong Kong SAR China Michael Page International (HK) Ltd Full timeA leading biotech company in Hong Kong seeks an experienced Associate Director, Regulatory Affairs to shape regulatory strategies and submissions for innovative biotech products. This pivotal role involves working closely with regulatory agencies and cross-functional teams to ensure compliance and drive the company’s growth. Candidates should have a strong...
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Hong Kong Island, Hong Kong SAR China Michael Page International (Hong Kong) Limited Full timeA leading biotech company in Hong Kong is seeking an Associate Director of Regulatory Affairs to develop and execute regulatory strategies. In this high-impact role, you will lead submissions, manage health authority interactions, and ensure compliance with evolving regulations. The ideal candidate has a strong regulatory background in biotech or...