Senior Regulatory Affairs Manager

Job Title
Senior Regulatory Affairs Manager

Job Description

Your role:

• Leading project teams for end-to-end regulatory affairs input and deliverables for new product introductions and product changes across the globe.
• Through end-to-end regulatory processes, ensuring safe and effective products / solutions are brought to market, on time, and sustained throughout life cycle via compliant, innovative regulatory strategies
• Provide critical input on regulatory risk assessments to support portfolio selection
• Collaborate and extend in 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.
• Building FDA regulatory submissions strategy for the products portfolio, providing related guidance to cross functional dedicated team and authoring 510K submissions.
  
  

• 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.
• Practical knowledge and experience with Advanced Visualization SaMD for diagnosis support (significant advantage).
• Extensive knowledge and authoring of FDA and other regulatory submissions (Pre-submissions, IDE, 510(k), PMA, Technical Files/Design Dossier);
• Extensive knowledge of MDD, MDR, MedDev’s, FDA QSR’s, FDA SaMD related and cybersecurity guidances , ISO 13485, ISO 14971, IEC 62304, and other for the market EMEA applicable regulations and standards for medical devices (preferably Software as Medical Device).
• 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 with 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 solution.
• Ideally, 5 years of leading product development team in satisfying registration requirements to bring products to market on time.
  
  

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