Principal Regulatory Affairs Specialist, Software

6 days ago


San Diego, California, United States Philips Full time
Principal Regulatory Affairs Specialist, Software (U.S. Hub based)

Clinical Integration and Insight (CII) is revolutionizing healthcare delivery at the point of care. Our Capsule Surveillance product is a cutting-edge clinical decision support software medical device (SaMD) that utilizes patented smart rules to provide actionable alerts to clinicians, anticipating patient deterioration.

This key position plays a crucial role in the global launch of Surveillance, collaborating closely with Clinical Affairs, Product Management, and R&D for its successful implementation.


Your role:
  • Ensure products meet all safety, regulatory, and quality standards in the CII business unit.
  • Lead project teams to deliver Regulatory Affairs input and requirements for new product launches and changes worldwide.
  • Ensure timely market entry and lifecycle maintenance through compliant, innovative regulatory strategies.
  • Provide vital input on regulatory risk assessments to guide portfolio decisions.
  • Establish strategic relationships with external stakeholders such as Notified Bodies, FDA, and Competent Authorities to facilitate rapid market access.
  • Foster strong cross-functional partnership between Regulatory Affairs and key stakeholders across the organization.
  • Develop regulatory submissions strategy and provide guidance to dedicated teams.
  • Ensure alignment across CII on regulatory matters and standards implementation.
  • Offer guidance on unique device identification (UDI) and implementation.
  • Support updates to regulatory body registrations and device listings.
  • Enhance Quality System regulatory aspects through process development and documentation.
  • Review and suggest improvements for design and manufacturing procedures to maintain quality and compliance.
  • Provide regulatory support during QMS audits.
  • Review and approve marketing, advertising, and labeling materials for regulatory adherence.

You're the right fit if:

With over 7 years of experience in Regulatory Affairs within the medical device industry, you have a strong background in SaMD and in-depth EUMDR knowledge. Experience in authoring 510(K) and Health Canada submissions is essential, along with a proven track record in managing global submissions. Possessing expertise in building relationships with external stakeholders is a must.

You are well-versed in medical device regulations, standards, and guidance, with a degree in a science-related field (Masters/PhD preferred).

You excel in communication, collaboration, and building partnerships to drive business success. With the ability to analyze diverse factors in business trends, you thrive in goal-oriented environments.


Join us at Philips, a leading health technology company, dedicated to ensuring everyone has access to quality healthcare. Make a meaningful impact on the lives of others by joining our team.


If this role sparks your interest and you possess most of the required experiences, we invite you to apply. Even if you don't meet all criteria, you may still be considered for this or other opportunities at Philips.


Additional Information
  • US work authorization required
  • No company relocation benefits provided
  • Equal employment opportunities for all candidates


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