Principal Regulatory Affairs Specialist
Philips
full-time
Posted on:
Location Type: Office
Location: Bothell • District of Columbia • Massachusetts • United States
Visit company websiteExplore more
Salary
💰 $128,520 - $205,632 per year
Job Level
About the role
- Lead and provide regulatory oversight for critical new product development projects
- Identify risks within regulatory strategies and propose balances
- Mentor and coach Philips Ultrasound regulatory professionals
- Negotiate with regulatory enforcement entities on regulatory filings
- Drive improvement in regulatory aspects of the Quality Management System
- Provide regulatory support for (pre-) clinical studies
- Offer guidance on global regulatory compliance procedures
- Represent Philips Ultrasound Regulatory Organization in internal and external audits
Requirements
- Minimum of 8+ years' Regulatory Affairs experience within FDA regulated Medical Device/HealthTech product environments
- Experience with Software as Medical Device (SaMD) and Ultrasound Imaging Devices highly desired
- Strong knowledge of US FDA, China NMPA, CE Marking, EU MDD/MDR, JPAL, Canadian CMDCAS
- Proven/successful preparation and submission of Technical Documentation, 510(k), De Novo, PMA, and registrations of medical devices globally
- Minimum of a Bachelor's Degree in Regulatory Affairs, Engineering, Life Sciences or comparable disciplines (Required)
- Master’s degree, RAC Certification desired
Benefits
- Generous PTO
- 401k (up to 7% match)
- HSA (with company contribution)
- Stock purchase plan
- Education reimbursement
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory oversightregulatory strategiesregulatory filingsQuality Management Systemregulatory supportglobal regulatory complianceTechnical Documentation510(k)De NovoPMA
Soft Skills
mentoringcoachingnegotiationrisk identificationguidance
Certifications
Bachelor's DegreeMaster’s DegreeRAC Certification