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Philips is seeking a Senior Regulatory Affairs Specialist for its Ultrasound division. The role involves securing product clearances and providing regulatory guidance for medical devices, with a focus on collaboration and compliance.
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Job Summary
Collaborate with regulatory teams and authorities to secure timely product clearances for Ultrasound devices.
Coordinate and prepare documentation for regulatory submissions to agencies such as the FDA, Health Canada, EU Competent Authorities, NMPA, and ANVISA.
Provide strategic guidance on clinical studies and evaluations, acting as the Regulatory Affairs representative for BG Ultrasound.
Matching Summary
Match Score: 75
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Philips is seeking a Senior Regulatory Affairs Specialist for its Ultrasound division. The role involves securing product clearances and providing regulatory guidance for medical devices, with a focus on collaboration and compliance.
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Salary
Murrysville, PA: $94,000 - $150,000; Plymouth, MN: $99,000 - $157,000; Cambridge, MA, Washington D.C., or Bothell, WA: $105,000 - $168,000
Skills & Requirements
Must-have
medical device regulatory affairs
FDA submissions
EU MDR Technical Documentation
global regulatory intelligence
product development guidance
Nice-to-have
SaMD or SiMD submissions
software development life cycle
artificial intelligence
data science
software testing
Key Requirements
5+ years of experience in medical device regulatory affairs
510(k) experience required
EU MDR Technical Documentation authoring experience required
Bachelor’s/Master’s Degree in science, engineering, or health-related discipline