Sr. Manager Regulatory Affairs

Job Title
Sr. Manager Regulatory Affairs

Job Description

The Senior Manager Regulatory Affairs will play a critical role within Philips' Clinical Informatics organization by leading regulatory projects for Philips' Disease Management Solution products , ensuring and maintaining global accurate regulatory strategy and market access , directly impacting the lives of patients around the world.

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.
• Building FDA regulatory submissions strategy for the products portfolio, providing related guidance to cross functional dedicated team and authoring 510K submissions.
• Leading and enabling 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.
• This Hybrid role may require travel up to 10%.

• You have a minimum of 10 years' experience in FDA Regulated Medical Device/HealthTech environments, with extensive knowledge and experience authoring 510K's, PMA's, Pre-submissions, IDE, Technical Files/Design Dossiers, and other regulatory submissions.
• You have 5 years' experience leading product development teams in satisfying registration requirements to bring products to market on time.
• You have detailed knowledge of MDD/MDR, MedDev's, FDA QSR's, FDA SaMD related and cybersecurity guidance's, ISO 13485, ISO 14971, IEC 62304, and applicable medical device regulations/standards for the EMEA market, including SaMD.
• You have practical knowledge and experience with Advanced Visualization SaMD for diagnosis support (highly desired).
• You have proven experience building strategic relationships with external stakeholders (e.g., Notified Bodies, FDA, Competent Authorities).
• You have experienced formulating and implementing global regulatory strategies to ensure compliance with worldwide regulations to improve product market access.
• You're an excellent communicator and collaborator who can build and maintain cross-functional partnerships in support of business successes.
• You're self-directed with a strong work ethic and with an ability to work in a goal-oriented environment.
• You have a minimum of a Master's degree (REQUIRED), preferably in Regulatory Affairs or a Life Sciences field.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position .
• 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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