Principal Regulatory Affairs Specialist
Philips
full-time
Posted on:
Location Type: Office
Location: Colorado Springs • California • Colorado • United States
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Salary
💰 $122,000 - $194,400 per year
Job Level
About the role
- Serve as a Principal Regulatory expert for 510(k) and EU MDR compliance
- Lead and influence global regulatory strategies to support market expansion
- Provide regulatory leadership and strategic guidance to internal stakeholders
- Drive preparation, review, and maintenance of EU MDR Technical Documentation
- Partner closely with hardware and systems engineering teams to support regulatory assessments
- Act as a key regulatory interface during Notified Body audits, regulatory inspections
- Provide regulatory input for post-market surveillance, vigilance, and change management
- Mentor and provide technical leadership to other Regulatory Affairs professionals
Requirements
- 8+ years of experience in Regulatory Affairs within FDA regulated Medical Device environments
- Proven expertise/knowledge in Regulations/Standards for hardware and Software
- Familiarity with FDA, EU MDR, Health Canada, Japan and other relevant international regulatory standards
- Minimum of a Bachelor's Degree in a Scientific or Technical discipline (Engineering, Biology, Biomedical Engineering, Pharmacy, Chemistry, or similar)
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 complianceEU MDR510(k)regulatory strategytechnical documentationpost-market surveillancevigilancechange managementregulatory assessmentsaudit preparation
Soft Skills
leadershipmentoringstrategic guidanceinfluencingcollaborationcommunicationstakeholder engagementtechnical leadership