Senior Regulatory Affairs Specialist (Hybrid - Acton, MA)
Insulet(2 months ago)
About this role
The Senior Regulatory Affairs Specialist leads domestic and international regulatory registration and submission activities for medical devices, partnering with Marketing, Product Development, Manufacturing, and Engineering. The role supports pre-market and post-market filings and ensures regulatory compliance across labeling, promotional materials, and product changes.
Required Skills
- Regulatory Submissions
- FDA Submissions
- CE Marking
- Labeling Review
- Promotional Review
- ECO Review
- Change Control
- ISO13485
- 21CFR820
- Cross Functional
+3 more
Qualifications
- B.S. / B.A.
- RAC Certification (preferred)
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