The Senior Regulatory Affairs Specialist will lead activities supporting domestic and international regulatory registrations and submissions for medical devices
Job Summary
The Senior Regulatory Affairs Specialist will lead activities supporting domestic and international regulatory registrations and submissions for medical devices.
This position offers a comprehensive benefits package including medical, dental, vision insurance, 401(k) with company match, paid time off, and employee wellness programs.
Insulet Corporation is dedicated to simplifying life for people with diabetes through its innovative Omnipod product platform and values hiring motivated individuals guided by shared values.
Matching Summary
The Senior Regulatory Affairs Specialist will lead activities supporting domestic and international regulatory registrations and submissions for medical devices.
Salary
Base: $91,700.00 - $137,525.00; Bonus/Equity: Eligible for incentive compensation; Benefits: Medical, dental, vision insurance, 401(k) with company match, PTO, wellness programs
Skills & Requirements
Must-have
Regulatory approval of medical devices
Reviewing labeling and promotional materials
Pre-market and post-market regulatory filings
Documentation for regulatory submissions
Review and approval of Engineering Change Orders
Hybrid working arrangement
Nice-to-have
Effective verbal and written communication
Team player with patient safety focus
Ability to manage multiple priorities
Proficient in Word, Excel, PowerPoint, Visio, Project
Ability to communicate at multiple organizational levels
Key Requirements
5+ years regulatory medical device experience
B.S. / B.A. or equivalent education and experience