The position is responsible for team leadership and development, and for driving cross-functional collaboration with R&D, engineering, quality, clinical, supply chain, and commercial teams to support the full product lifecycle.
This role requires deep expertise in medical device regulations (particularly for high-risk Class III active medical devices, cybersecurity, software), strong strategic thinking, communication and influencing skills, and leadership capability to effectively manage regulatory risks and enable business success.
The role has a direct impact on registration success, approval timelines, compliance status, and business continuity.
Basic Requirement, including Education and/or Knowledge and/or Training and/or key
Bachelor’s degree or above in biomedical engineering, medical science, materials science, mechanical/biomechanical engineering, or other life science disciplines,
Minimum 8 years of regulatory affairs or relevant experience in medical devices, including at least 3–5 years in Class III high-risk devices (e.g., active medical device or implanted medical devices),
Experience in a multinational medical device company or leading complex regulatory projects is preferred,
Proven experience in
New product registration and market authorization (innovative devices preferred)
Regulatory strategy development and execution
Lifecycle management (variations and renewals)
Health authority interactions with NMPA/CMDE
Required Skills
Preferred Skills
Analytical Reasoning, Business Writing, Compliance Risk, Fact-Based Decision Making, Industry Analysis, Legal Support, Mentorship, Organizing, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Technical Credibility
