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Philips UK is seeking a Senior Regulatory Specialist with extensive experience in regulatory affairs within the medical device industry. The ideal candidate will manage regulatory submissions, provide guidance on product development, and ensure compliance with global regulations.
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Matching Summary
Match Score: 75
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Philips UK is seeking a Senior Regulatory Specialist with extensive experience in regulatory affairs within the medical device industry. The ideal candidate will manage regulatory submissions, provide guidance on product development, and ensure compliance with global regulations.
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Salary
Not specified; Not specified; Not specified
Skills & Requirements
Must-have
510(k) submission experience
EU MDR Technical Documentation
FDA 21 CFR 820 Quality System Regulations
ISO 13485 standard application
Global regulatory landscape monitoring
Nice-to-have
Mentoring and coaching capabilities
Process improvement leadership
Strategic product development involvement
Negotiation with regulators
Cross-functional team collaboration
Key Requirements
Minimum 7-10 years medical device industry experience
Master's degree in engineering or regulatory affairs preferred
Bachelor's degree with demonstrated medical device experience