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 extensive regulatory approaches for intricate new devices and modifications in the post-market phase within Philips' Ultrasound division.

Your responsibilities:
  • Oversee critical new product development initiatives, ensuring regulatory compliance throughout the product lifecycle while adhering to cutting-edge standards.
  • Craft regulatory strategies and articulate potential risks associated with these strategies in relation to project timelines, proposing solutions to mitigate risks for project teams and Regulatory Affairs Management.
  • Lead discussions and negotiations with regulatory authorities regarding submissions at the reviewer level.
  • Offer insights on global compliance matters, including CE Marking, product registrations, and clinical evaluations in line with EU MDR, ISO 13485, ISO 14155, as well as compliance with FDA guidelines and other international regulatory requirements pertinent to Philips Ultrasound's global objectives.
  • Ensure adherence to existing regulatory protocols and, when necessary, develop or revise procedures in response to new regulatory mandates.
  • Provide regulatory guidance for (pre)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; enhance regulatory aspects of the Quality Management System and assist in creating processes and documentation to maintain 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 available for this position. Candidates must reside in or be within commuting distance to designated locations.
Ideal candidate profile:
  • 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 solid understanding of relevant global regulatory requirements, with the ability to adapt to business needs and strong communication skills.
  • A minimum of a Bachelor's degree in Regulatory Affairs, a technical or business field is required; an Advanced Degree (MS/PhD) is desirable. 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; candidates requiring sponsorship for a work-authorized visa will not be considered.
About Philips:

Philips is a health technology organization dedicated to the belief that every individual matters, striving to ensure that everyone has access to quality healthcare. Contribute to meaningful work that enhances the lives of others.
  • Explore our business model.
  • Discover our rich and dynamic history.
  • Learn about our mission.
  • Review our employee benefits.

Philips Transparency Details

The compensation range for this position is $104,000 to $178,000 annually, with actual base pay varying based on factors such as job-related knowledge, skills, experience, business needs, geographical location, and internal equity.

Additional compensation, including annual incentive bonuses, sales commissions, or long-term incentives, may also be available. Employees can participate in our comprehensive Philips Total Rewards benefits program, which includes generous PTO, 401k matching, HSA contributions, stock purchase plans, education reimbursement, and more. Details about our benefits can be found on our website.

At Philips, it is uncommon for an individual to be hired at or near the top of the compensation range, as decisions are based on the specific circumstances of each case.

#LI-PH1

This requisition will remain active for a period but may close earlier if a suitable candidate is identified or business needs change. Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.

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