Principal Regulatory Affairs Specialist (Hybrid)
Insulet(6 months ago)
About this role
The Principal Regulatory Affairs Specialist will lead strategic regulatory initiatives and serve as the subject matter expert supporting domestic and international market authorization and compliance for medical devices. The role partners cross-functionally with Marketing, New Product Development, Manufacturing, and Engineering to guide products through development, approval, and post-market activities.
Required Skills
- Regulatory Affairs
- Regulatory Strategy
- Submission Management
- Pre-Market Filings
- Documentation
- Compliance
- Clinical Evaluation
- Clinical Studies
- Mobile Applications
- Cloud Systems
+7 more
Qualifications
- B.S. / B.A.
- RAC Certification (preferred)
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