Senior Regulatory Affairs Leader

2 weeks ago

Gainesville, Florida, United States Philips Full time
Job Title
Senior Regulatory Affairs Leader

Job Overview

The Senior Regulatory Affairs Leader will be instrumental within Philips' Clinical Informatics division by steering regulatory initiatives for Philips' Disease Management Solution offerings, ensuring and upholding a precise global regulatory strategy and market accessibility, significantly influencing patient outcomes worldwide.

Your Responsibilities:
  • Directing project teams for comprehensive regulatory affairs contributions and outputs for new product launches and modifications globally.
  • Through thorough regulatory processes, guaranteeing that safe and effective products/solutions are introduced to the market promptly and maintained throughout their lifecycle via compliant and innovative regulatory strategies.
  • Offering essential insights on regulatory risk evaluations to aid in portfolio selection.
  • Fostering and expanding proactive, strategic partnerships with external entities (Notified Bodies, FDA, Competent Authorities, and other Regulatory organizations) to ensure that requirements are identified early during strategy formulation, facilitating swift market access in conjunction with future innovations.
  • Developing FDA regulatory submission strategies for the product portfolio, providing related guidance to dedicated cross-functional teams and authoring 510K submissions.
  • Facilitating and empowering robust cross-functional collaboration between Regulatory Affairs and all key stakeholders, including R&D, Marketing, Quality, Clinical Affairs, and other functions at all levels within the organization, as well as local Regulatory Affairs teams in the Philips international markets.
  • This Hybrid role may necessitate travel up to 15%.
  • Company relocation benefits will not be provided 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 environments, with extensive expertise in authoring 510K's, PMA's, Pre-submissions, IDE, Technical Files/Design Dossiers, and other regulatory submissions.
  • 5 years' 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 (highly preferred).
  • Demonstrated ability to build 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 to enhance product market access.
  • Exceptional communication and collaboration skills to build and sustain cross-functional partnerships supporting business success.
  • 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.
  • Must be able to successfully perform the minimum Physical, Cognitive, and Environmental job requirements with or without accommodation for this position.
  • US work authorization is a prerequisite for employment. The company will not consider candidates requiring sponsorship for a work-authorized visa, now or in the future.
  • Candidates must reside within commuting distance to specified locations or be willing/able to relocate.
About Philips:

Philips is a health technology organization dedicated to the belief that every individual matters, and we strive until 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.
  • Learn more about our purpose.
  • Read more about our employee benefits.
Philips is committed to diversity and inclusion.

Philips Transparency Details:

The pay range for this position is $104,000 to $178,000, annually. The actual base pay offered may vary depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.

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