Regulatory Affairs Manager

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