Sr. Regulatory Affairs Specialist, Omnipod 5 Expansion (hybrid - Acton, Ma)

Insulet Corporation

Acton, MA, US
Base: $91,700.00 - $137,525.00; bonus/equity: not ...
Hybrid
5+ years regulatory experience
Regulatory support for product development
Knowledge of regulatory guidelines
The Senior Regulatory Affairs Specialist will lead activities supporting regulatory registrations and submissions

Job Summary

  • The Senior Regulatory Affairs Specialist will lead activities supporting regulatory registrations and submissions.
  • This role involves collaboration with Marketing, New Product Development, Manufacturing, and Engineering teams.
  • Insulet Corporation offers a comprehensive benefits package including medical, dental, and vision insurance.

Matching Summary

The Senior Regulatory Affairs Specialist will lead activities supporting regulatory registrations and submissions.

Salary

Base: $91,700.00 - $137,525.00; Bonus/Equity: Not specified; Benefits: Comprehensive benefits package

Skills & Requirements

Must-have

  • 5+ years regulatory experience
  • Regulatory support for product development
  • Knowledge of regulatory guidelines

Nice-to-have

  • Effective communication skills
  • Team player with patient safety focus
  • Ability to manage multiple priorities

Key Requirements

  • B.S. / B.A. or equivalent
  • RAC Certification preferred
  • Experience with 21 CFR 820 and ISO 13485

Work Rights

Not specified

Tailored Resume

Cover Letter