The pyy range for this position in colorado spring...
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Global regulatory strategies
Eu mdr technical documentation
System-level risk management
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Philips UK is seeking a Principal Regulatory Affairs Specialist to lead regulatory strategies for medical devices, ensuring compliance with global regulations, particularly for complex hardware systems. The ideal candidate will have extensive experience in regulatory affairs, particularly with FDA 510(k) and EU MDR requirements, and will play a key role in mentoring and guiding cross-functional teams.
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Job Summary
Play a critical leadership role as a Senior regulatory subject-matter expert, ensuring Philips medical device products are safe, effective, and compliant with applicable global regulatory requirements.
Lead and influence global regulatory strategies to support market expansion and lifecycle management, with emphasis on system-level hardware integration considerations for US, EU, Japan, Canada, and other international markets as required.
Communicate complex regulatory topics clearly and effectively to senior leadership and cross-functional teams, enabling informed decision-making on hardware design tradeoffs and system integration risks.
Matching Summary
Match Score: 75
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Philips UK is seeking a Principal Regulatory Affairs Specialist to lead regulatory strategies for medical devices, ensuring compliance with global regulations, particularly for complex hardware systems. The ideal candidate will have extensive experience in regulatory affairs, particularly with FDA 510(k) and EU MDR requirements, and will play a key role in mentoring and guiding cross-functional teams.
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Salary
The pay range for this position in Colorado Springs, CO is $122,000 to $194,400; The pay range for this position in San Diego, CA, Bedford, MA and Cambridge, MA is $137,000 to $217,728; The pay range for this position in Plymouth, MN is $128,000 to $204,120
Skills & Requirements
Must-have
Global regulatory strategies
EU MDR Technical Documentation
System-level risk management
International regulatory submissions
Notified Body audits
Nice-to-have
Mentoring regulatory professionals
Communicating complex topics
Experience with SaMD
Key Requirements
8+ years' experience in Regulatory Affairs
FDA regulated Medical Device environments
Bachelors’ Degree in a Scientific or Technical discipline