Sr. Regulatory Affairs Specialist, Omnipod 5 Expansion (Hybrid - Acton, MA)
Insulet(2 months ago)
About this role
The Senior Regulatory Affairs Specialist leads regulatory efforts to support domestic and international medical device registrations and submissions. The role partners with Marketing, Product Development, Manufacturing, and Engineering to ensure regulatory compliance across product lifecycle and support interactions with regulatory agencies. It contributes to regulatory strategy for pre-market and post-market activities.
Required Skills
- Regulatory Submissions
- Labeling Review
- Promotional Review
- Packaging Review
- ECO Review
- FDA Submissions
- CE Marking
- ISO 13485
- Clinical Support
- Documentation
+5 more
Qualifications
- BS/BA or Equivalent
- RAC Certification (Preferred)
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