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Regulatory Affairs Senior Manager
2 months ago
Regulatory Affairs Senior Manager
Job SummaryPhilips is seeking a highly experienced Regulatory Affairs Senior Manager to lead regulatory projects for Philips Clinical Informatics organization. The successful candidate will play a critical role in ensuring and maintaining global accurate regulatory strategy and market access for Philips Disease Management Solution products.
Key Responsibilities- Regulatory Project Leadership
- Lead project teams for end-to-end regulatory affairs input and deliverables for new product introductions and product changes across the globe.
- Ensure safe and effective products/solutions are brought to market, on time, and sustained throughout life cycle via compliant, innovative regulatory strategies.
- Regulatory Risk Management
- Provide critical input on regulatory risk assessments to support portfolio selection.
- Stakeholder Collaboration
- 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.
- Regulatory Strategy Development
- Build FDA regulatory submissions strategy for the products portfolio, providing related guidance to cross-functional dedicated team and authoring 510K submissions.
- Cross-Functional Partnership
- 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.
- Travel and Relocation
- This hybrid-based role may require travel up to 15%.
- Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to one of the 8 Philips site locations specified on the Job Posting.
- Experience
- A minimum of 10 years experience in FDA Regulated Medical Device/HealthTech environments, with extensive knowledge and experience authoring 510Ks, PMAs, Pre-submissions, IDE, Technical Files/Design Dossiers, and other regulatory submissions.
- 5 years experience leading product development teams in satisfying registration requirements to bring products to market on time.
- Knowledge
- Detailed knowledge of MDD/MDR, MedDevs, FDA QSRs, FDA SaMD related and cybersecurity guidances, ISO 13485, ISO 14971, IEC 62304, and applicable medical device regulations/standards for the EMEA market, including SaMD.
- Practical knowledge and experience with Advanced Visualization SaMD for diagnosis support (highly desired).
- Skills
- Proven experience building strategic relationships with external stakeholders (e.g., Notified Bodies, FDA, Competent Authorities).
- 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.
- Education
- A minimum of a Bachelor's degree (REQUIRED), preferably in Regulatory Affairs or a Life Sciences field. Master's degree desired.
- Work Authorization
- US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
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