Manager, Post Market Compliance - Global Product Monitoring (hybrid - Acton, Ma)

Insulet Corporation

Acton, MA, US
Base: $112,300.00 - $168,400.00; bonus/equity: eli...
Hybrid
8+ years work experience
4+ years post-market surveillance
Fda eu mdr regulatory knowledge
The role involves developing and maintaining a Post Market Surveillance System consistent with FDA, Health Canada, and EU MDR regulations

Job Summary

  • The role involves developing and maintaining a Post Market Surveillance System consistent with FDA, Health Canada, and EU MDR regulations.
  • Candidates will serve as the global process owner for Requests for Additional Information (RFAIs) and drive improvements based on performance data.
  • The company offers a comprehensive benefits package including medical, dental, vision insurance, and a 401(k) with company match.

Matching Summary

The role involves developing and maintaining a Post Market Surveillance System consistent with FDA, Health Canada, and EU MDR regulations.

Salary

Base: $112,300.00 - $168,400.00; Bonus/Equity: Eligible for incentive compensation; Benefits: Medical, dental, vision, 401(k) match, PTO

Skills & Requirements

Must-have

  • 8+ years work experience
  • 4+ years post-market surveillance
  • FDA EU MDR regulatory knowledge
  • Global cross-functional collaboration
  • Regulatory authority inquiry response

Nice-to-have

  • Diabetes therapeutic area knowledge
  • Strong emotional intelligence
  • Ability to influence without authority
  • Fluency in French language preferred
  • Experience with ISO 13485 standards

Key Requirements

  • BS/BA degree required
  • 8+ years total work experience
  • 4+ years in MedTech post-market vigilance
  • Proven experience responding to regulatory inquiries

Work Rights

Not specified

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