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Senior Regulatory Affairs Manager
2 months ago
The Senior Regulatory Affairs Manager will be instrumental within Philips' Clinical Informatics division, overseeing regulatory initiatives for the company's Disease Management Solution offerings. This role is vital in ensuring a precise global regulatory approach and facilitating market access, which significantly influences patient outcomes worldwide.
Key Responsibilities:
- Directing project teams to deliver comprehensive regulatory affairs contributions for new product launches and modifications on a global scale.
- Implementing thorough regulatory processes to guarantee that safe and effective products are introduced to the market punctually and maintained throughout their lifecycle through compliant and innovative regulatory strategies.
- Offering essential insights on regulatory risk evaluations to aid in portfolio selection.
- Fostering proactive and strategic relationships with external entities (Notified Bodies, FDA, Competent Authorities, and other regulatory organizations) to ensure early identification of requirements during strategy formulation, facilitating swift market access for the current product lineup and future innovations.
- Developing regulatory submission strategies for the product portfolio, providing guidance to cross-functional teams, and authoring 510K submissions.
- Promoting robust cross-functional collaboration between Regulatory Affairs and key stakeholders, including R&D, Marketing, Quality, Clinical Affairs, and other departments at all organizational levels, as well as local Regulatory Affairs teams in Philips' international markets.
- This hybrid role may involve travel up to 15%.
- Relocation benefits are not available for this position; candidates must reside in or be within commuting distance to specified Philips site locations.
Qualifications:
- A minimum of 10 years' experience in FDA-regulated Medical Device/HealthTech sectors, with extensive expertise in authoring 510K's, PMA's, Pre-submissions, IDE, Technical Files/Design Dossiers, and other regulatory documents.
- At least 5 years of experience leading product development teams to meet registration requirements for timely market introduction.
- In-depth knowledge of MDD/MDR, MedDev's, FDA QSR's, FDA SaMD-related and cybersecurity guidelines, ISO 13485, ISO 14971, IEC 62304, and relevant medical device regulations/standards for the EMEA market, including SaMD.
- Practical experience with Advanced Visualization SaMD for diagnostic support is highly desirable.
- Proven track record in establishing strategic relationships with external stakeholders (e.g., Notified Bodies, FDA, Competent Authorities).
- Experience in formulating and executing global regulatory strategies to ensure compliance with international regulations, enhancing product market access.
- Exceptional communication and collaboration skills, capable of building and sustaining cross-functional partnerships to support business objectives.
- Self-motivated with a strong work ethic and the ability to thrive in a goal-oriented environment.
- A minimum of a Bachelor's degree (REQUIRED), preferably in Regulatory Affairs or a Life Sciences discipline; a Master's degree is preferred.
- Ability to meet the minimum physical, cognitive, and environmental job requirements with or without accommodation.
- US work authorization is a prerequisite for employment; candidates requiring sponsorship for a work-authorized visa will not be considered.
- Must reside within commuting distance to the specified Philips site or be willing to relocate.
About Philips:
Philips is a health technology organization committed to the belief that every individual matters. We strive to ensure that everyone has access to quality healthcare. Join us in making a difference in the lives of others.
- Learn more about our business.
- Discover our rich and exciting history.
- Understand our purpose.
- Explore our employee benefits.
Philips is dedicated to diversity and inclusion in the workplace, and we encourage candidates with diverse backgrounds to apply.
