Sr Director, Global Product Monitoring Safety & Surveillance (hybrid)

Insulet

Acton, MA, US
Base: $193,800 - $290,700; bonus/equity: may be el...
Hybrid
Post-market surveillance system management
Regulatory compliance with global medical device laws
People management and team leadership
Insulet is dedicated to enabling customers to enjoy simplicity, freedom, and healthier lives through innovative wearable insulin delivery technology

Job Summary

  • Insulet is dedicated to enabling customers to enjoy simplicity, freedom, and healthier lives through innovative wearable insulin delivery technology.
  • The Senior Director will lead a global team responsible for post-market safety, surveillance, and compliance, ensuring regulatory adherence and driving operational excellence.
  • The position offers a comprehensive benefits package and the opportunity to work in a hybrid environment near Acton, MA, with an annual base salary range of $193,800 to $290,700.

Matching Summary

Insulet is dedicated to enabling customers to enjoy simplicity, freedom, and healthier lives through innovative wearable insulin delivery technology.

Salary

Base: $193,800 - $290,700; Bonus/Equity: May be eligible; Benefits: Medical, dental, vision, 401(k) match, PTO, wellness programs

Skills & Requirements

Must-have

  • post-market surveillance system management
  • regulatory compliance with global medical device laws
  • people management and team leadership
  • cross-functional collaboration
  • quality management system expertise
  • patient safety and risk management

Nice-to-have

  • continuous process improvement culture
  • strategic operational planning
  • mentoring and coaching skills
  • ability to handle ambiguity
  • strong interpersonal communication
  • global stakeholder engagement

Key Requirements

  • BS/BA degree with 12+ years experience
  • 8+ years supervisory experience in medical devices
  • 6+ years in quality assurance/regulatory affairs
  • 4+ years leading post-market surveillance teams
  • experience with 21 CFR 803, 806, 820, ISO 13485, EU MDR
  • experience managing global distributed teams
  • experience engaging regulatory authorities
  • preferred certifications: ASQ CQE/CSQE, RAPS RAC, Lean Six Sigma

Work Rights

Not specified

Tailored Resume

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