Principal Regulatory Affairs Specialist
Philips
full-time
Posted on:
Location Type: Hybrid
Location: District of Columbia • Florida • United States
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Salary
💰 $137,000 - $217,000 per year
Job Level
About the role
- Lead and provide regulatory oversight for new product development projects
- Negotiate directly with regulatory enforcement entities on regulatory filings
- Mentor and coach Philips Ultrasound regulatory professionals
- Drive improvement in regulatory aspects of the Quality Management System
- Provide regulatory support for clinical studies and recommend optimization strategies
- Provide guidance on regulatory compliance procedures globally
Requirements
- 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
- Master’s degree, RAC Certification desired
Benefits
- 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 filingsregulatory compliance proceduresTechnical Documentation510(k)De NovoPMAmedical device registrationsSoftware as Medical Device (SaMD)Ultrasound Imaging Devices
Soft Skills
mentoringcoachingnegotiationguidanceimprovement driving
Certifications
RAC Certification