Senior Regulatory Affairs Specialist

Philips

Full time Business Operations Specialists
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Location
Bothell, Washington, United States
Posted
July 08, 2026

Job Description

JOB DESCRIPTION

Job Title

Senior Regulatory Affairs Specialist

Job Description

Senior Regulatory Affairs Specialist, Ultrasound

The Senior Regulatory Affairs Specialist for Ultrasound collaborates with regulatory teams and authorities to secure timely product clearances. Responsibilities include coordinating and preparing regulatory submission documents for agencies such as the FDA, Health Canada, EU Competent Authorities, NMPA, and ANVISA, and offering strategic guidance on clinical studies and evaluations.

Your role:

  • Act as an ambassador of Philips values and ensure compliance with all relevant business processes and regulatory procedures.
  • Serve as the Regulatory Affairs representative for BG Ultrasound, providing guidance on regulatory issues related to product development, labeling, and marketing strategies.
  • Coordinate and prepare documentation for regulatory submissionsโ€”such as Product Repor...