Regulatory Affairs Manager

在 Johnson & Johnson，我们相信健康就是一切。 我们在医疗创新方面的实力使我们能够建立一个能够预防，治疗和治愈复杂疾病的世界,在这个世界中,治疗更智能，侵入性更低,并且解决方案是个性化的。 凭借我们在创新医学和医疗技术方面的专业知识,我们处于独特的地位,能够在当今的全套医疗保健解决方案中进行创新,以实现未来的突破,并对人类的健康产生深远的影响。 如需了解更多信息，请访问jnj.com

在我们的信条指引下，强生公司对全球范围内与我们共事的员工负有责任。我们提供一个包容的工作环境，在这里每个人都被视为独立的个体。在强生，我们尊重员工的多样性和尊严，并认可他们的价值。

工作职能：Regulatory Affairs Group

作业子功能：Regulatory Affairs

职位类别：People Leader

所有职位发布位置：Beijing, China

职位描述：
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

Required Skills:

Preferred Skills:
产品授权, 法规遵从, 法律支持, 分析推理, 风险规范, 风险评估, 公共政策, 基于事实的决策制定, 技术可信度, 监管环境, 监管开发, 监管事务管理, 商务写作, 师徒制, 行业分析, 战略性思维, 组织