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

Insulet

Acton, MA, US
Base: $112,300.00 - $168,400.00; bonus/equity: eli...
Hybrid
Post-market surveillance system management
Regulatory compliance with fda and global standards
Cross-functional global collaboration
Insulet is dedicated to improving the lives of patients with insulin-requiring diabetes through innovative wearable technology and is experiencing significant global growth

Job Summary

  • Insulet is dedicated to improving the lives of patients with insulin-requiring diabetes through innovative wearable technology and is experiencing significant global growth.
  • The Manager of Post Market Compliance will oversee the development and execution of post-market surveillance activities, ensuring compliance with global regulations and collaborating with internal and external stakeholders.
  • The company offers a comprehensive benefits package including medical, dental, vision insurance, 401(k) with company match, paid time off, and wellness programs.

Matching Summary

Insulet is dedicated to improving the lives of patients with insulin-requiring diabetes through innovative wearable technology and is experiencing significant global growth.

Salary

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

Skills & Requirements

Must-have

  • Post-market surveillance system management
  • Regulatory compliance with FDA and global standards
  • Cross-functional global collaboration
  • Regulatory authority inquiry response
  • Medical device vigilance and surveillance
  • Technical and clinical content advisory

Nice-to-have

  • Strong emotional intelligence
  • Ability to influence without authority
  • Adaptability to ambiguity
  • Continuous improvement mindset
  • Global project team leadership

Key Requirements

  • BS/BA degree with 8+ years experience
  • 4+ years post-market surveillance in MedTech
  • Experience responding to regulatory inquiries
  • Knowledge of global medical device regulations
  • Experience managing global cross-functional teams

Work Rights

Not specified

Tailored Resume

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