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Sr. Regulatory Affairs Specialist
On-site · Kwai Chung, Kwai Tsing, Hong Kong
Job Summary
Regulatory Affairs Specialist III in Hong Kong focusing on IVDs and medical devices. Lead registration strategy and documentation with Hong Kong authorities, monitor regulatory changes, ensure lifecycle compliance, support post-market surveillance, and coordinate internal/external audits. Collaborate with cross-functional teams to drive regulatory strategies for timely market entry, maintain high compliance standards, and serve as a liaison to regulators and partners. Requires a Bachelor’s in Life Sciences or related field and 2+ years in regulatory affairs for IVDs/medical devices; English proficiency is essential, Mandarin a plus.
Required Qualifications
- Bachelor’s degree in Life Sciences, Biomedical Engineering, or related field
- 2+ years of experience in regulatory affairs for IVDs or medical devices, preferably with exposure to Hong Kong MDACS
- Exceptional communication abilities and a proactive approach to achieving outcomes
- Strong problem identification, analysis, and solution-providing abilities
- Project management and multitasking under tight deadlines
- Strong written and spoken English; Mandarin is a plus
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