Philips Senior Regulatory Affairs Team Lead 

Germany, Hesse 

271356288

Your role:

• Leading a global Regulatory Affairs team for end-to-end regulatory affairs input and deliverables for new product introductions and product changes across the globe.
• Represent the Regulatory Affairs function at the DCP leadership team.
• Through end-to-end regulatory processes, ensuring safe and effective products/solutions are brought to market, on time, and sustained throughout the life cycle via compliant, innovative regulatory strategies
• Provide critical input on regulatory risk assessments to support portfolio selection within DPI
• Collaborate and extend proactive, strategic relationships with external stakeholders (Notified Bodies, FDA, Competent Authorities, and other Regulatory bodies) to ensure that requirements are known early during strategy development, enabling rapid market access with the current portfolio in connection with future innovations.
• Lead and enable strong cross-functional partnership between Regulatory Affairs and all key stakeholders including R&D, Marketing, Quality, Clinical Affairs, and other functions at all levels within the business, and the local Regulatory Affairs teams in the Philips international markets organization.
• Hiring and developing critical talent within the global Regulatory Affairs team through creating and sustaining robust development plans, ongoing coaching and feedback, and identifying and addressing capabilities gaps, may become a part of your responsibility.

You're the right fit if:

• Master’s degree, preferably in a life-scientific field;
• A minimum of 10 years of experience working in Regulatory Affairs within a medical device industry.
• Extensive knowledge and authoring of FDA and other regulatory submissions (Pre-submissions, IDE, 510(k), PMA, Technical Files/Design Dossier);
• Extensive knowledge of MDD, EU-MDR/EU-IVDR, MedDev’s, FDA QSR’s, ISO 13485 & 14155, and others for the market EMEA applicable regulations and standards for Hardware/Software medical devices.
• Experienced in strategic relationships with external stakeholders (e.g. Notified Bodies, FDA, Competent Authorities);
• Experienced in formulating and implementing global regulatory strategies to ensure compliance with worldwide regulations to improve product market access;
• An excellent communicator and collaborator who can build and maintain cross-functional partnerships in support of business successes.
• Self-directed with a strong work ethic and an ability to work in a goal-oriented environment.
• An ability to work on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends. Follows processes and operational policies in selecting methods and techniques for solutions.
• Ideally, 5 years of people management – with a strong track record in successfully leading a Regulatory Affairs team to bring products to market on time.
• Experience with SaMD, AI, and/or digital health is a significant advantage.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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