Senior Regulatory Affairs Leader

2 weeks ago

Bothell, Washington, United States Philips Full time
Job Title
Senior Regulatory Affairs Leader - Ultrasound

Job Description

The Senior Regulatory Affairs Leader will be instrumental in formulating detailed regulatory strategies for intricate new devices and modifications in the Ultrasound sector at Philips.

Your responsibilities:
  • Oversee critical new product development initiatives, ensuring regulatory compliance throughout the product lifecycle and maintaining adherence to cutting-edge standards.
  • Craft regulatory strategies and articulate risks associated with these strategies in relation to project timelines, proposing solutions to mitigate project risks to project teams and Regulatory Affairs Management.
  • Lead discussions and negotiations with regulatory authorities regarding regulatory submissions at the reviewer level.
  • Offer insights on global compliance requirements, including CE Marking, product registrations, and clinical evaluations in line with EU MDR, ISO 13485, ISO 14155, and other international regulations relevant to Philips Ultrasound's global objectives.
  • Ensure adherence to current regulatory protocols and, when necessary, develop or revise procedures in response to new regulatory requirements.
  • Provide regulatory support for clinical studies, including advising on strategies to enhance clinical study approvals and reviewing clinical study protocols.
  • Represent Philips during internal and external audits conducted by regulatory bodies or Notified Bodies as required.
  • Mentor and guide Philips regulatory professionals in their career development; drive enhancements in regulatory aspects of the Quality Management System and in the development of processes and documentation to uphold an effective Quality System.
  • Reporting to the Director of Regulatory Affairs-Ultrasound, you will collaborate with global regulatory affairs team members, Engineering, R&D, Manufacturing, and other cross-functional teams.
  • This Hybrid role may involve travel up to 10%.
  • Relocation benefits will not be provided for this position; candidates must reside in or near designated locations.
Qualifications:
  • A minimum of 7 years' experience in FDA-regulated Medical Device Regulatory Affairs, with demonstrated expertise in U.S. FDA 510K, China NMPA, and EU MDR, along with international regulatory submission experience.
  • A proven history of successfully preparing and submitting Technical Documentation, 510(k), De Novo, PMA, and global medical device registrations.
  • Experience with Software as a Medical Device (SaMD) and Ultrasound Imaging Devices is preferred.
  • A strong grasp of relevant global regulatory requirements, with the ability to adapt to business needs and excellent communication skills.
  • A minimum of a Bachelor's degree in Regulatory Affairs, a technical or business discipline is required; an Advanced Degree (MS/PhD) is desired. RAC certification is preferred.
  • Ability to meet the minimum physical, cognitive, and environmental job requirements with or without accommodation.
  • U.S. work authorization is a prerequisite for employment; the company will not consider candidates requiring sponsorship for a work-authorized visa.
About Philips:

Philips is a health technology organization committed to the belief that every individual matters, striving to ensure access to quality healthcare for all. Contribute to meaningful work that enhances the lives of others.
  • Explore our business.
  • Discover our rich history.
  • Learn about our purpose.
  • Review our employee benefits.
Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.

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