Philips Regulatory Affairs Manager 

China, Jiangsu, Suzhou City 

942842331

Regulatory Affairs Manager

Your role:

• Leading MR Regulatory Affairs team of MRI Business Unit in China from end to end (Regulatory Strategies and Submission) value-added regulatory affairs input and deliverables for new product introductions and product changes in China.

• Leading the development and deployment of innovative Regulatory strategies to efficiently and compliantly bring products to the market and maintain them compliantly to support business growth.

• Leading strategy and execution of functional excellence to improve the performance of the regulatory function and ultimately bring increased value to the MR Business Unit

• Providing interpretation of NMPA regulations and Standards to MR Business Unit for early adoption of the requirements into our Innovations.

• Providing critical input on regulatory risk assessments to support portfolio selection

• Building proactive, robust, strategic relationships with external stakeholders (NMPA, Notified Bodies, State Authorities, and Industry Associations) to influence and shape the external regulatory landscape across the domains relevant to the partnership agenda

• Leading and enabling strong cross-function partnerships between Regulatory Affairs and all key stakeholders, including R&D, Marketing, Quality, Clinical Affairs, and other functions within the Business Unit.

• Responsible for the hiring and developing of critical talent within the Global Regulatory Affairs Team through creating and sustaining robust career & development plans, ongoing coaching and feedback, and identifying and addressing gaps in capabilities and competencies.

You're the right fit if you have the following:

• Bachelor's degree, preferably in an engineering or life-scientific field

• A minimum of 8-10 years of experience working in Regulatory Affairs within the Medical Device industry (Experience with SaMD, AI, and/or digital health is a significant advantage)

• Extensive experience and knowledge required of global medical device regulations, requirements, and standards

• 10 years of experience in people management – with a strong track record in successfully leading a Regulatory Affairs team

• Proven track record of leading in a matrix organization, leading cross-functional and diverse teams with challenging goals

• Experienced in strategic relationships with external stakeholders (Competent Authorities, Industry Associations)

• Experience with successfully leading, preparing, and submitting Design Dossiers, 510(k), NMPA Submission,Technical /Design Dossiers, and international documents or medical device registration worldwide.

Onsite roles require full-time presence in the company’s facilities.
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