Regulatory Affairs Manager

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Principal Duties and Responsibilities (General Summary, essential functions and authorities, etc.)

• Regulatory Affairs Manager operates under the leadership of the RA Director and is responsible for end-to-end regulatory strategy and execution for the surgical vision equipment and related disposable product portfolio in China, covering product development, registration, market launch, and lifecycle management.
• This role leads and coordinates multiple complex regulatory projects, defines optimal regulatory strategies aligned with China requirements and global objectives, and ensures high-quality and timely approvals. The role also serves as a key interface with Chinese regulatory authorities (e.g., NMPA/CMDE) and leads critical regulatory interactions and responses.
• 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

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