VP, Post Market Surveillance

Responsibilities

• Serve as the executive owner of global Post-Market Surveillance (PMS), providing strategic vision and a long-term roadmap aligned with company growth.
• Act as a senior advisor to executive leadership and the Board on patient safety, post-market risk, and regulatory exposure.
• Build, scale, and inspire a high-performing global organization, including regional and functional leaders.
• Design and evolve a globally harmonized, scalable PMS operating model that is inspection-ready.
• Maintain executive accountability for FDA MDR, EU MDR Vigilance, PMCF, PSURs, and evolving global post-market requirements.
• Oversee enterprise signal detection, trending, and escalation across complaints, adverse events, and digital health data.
• Advance digital, data-driven surveillance capabilities for software-enabled and connected therapies.

Requirements

• Bachelor's degree in Engineering, Life Sciences, or a related discipline.
• 15+ years of experience in medical device quality, regulatory affairs, or post-market surveillance.
• 7–10+ years in senior, enterprise-level leadership roles with global scope.
• Deep expertise in FDA MDR and EU MDR compliance.
• Strong knowledge of ISO 13485 and ISO 14971 standards.
• Proven track record of leading large, complex, regulated organizations through growth and change.

Preferred Qualifications

• Advanced degree such as MS, PhD, MD, or PharmD.
• Experience with software-enabled, connected, or digital health medical devices.

Benefits

• Medical, dental, and vision insurance.
• 401(k) with company match.
• Paid time off (PTO).
• Additional employee wellness programs.

About the Company

Insulet is an innovative medical device company dedicated to simplifying life for people with diabetes through its Omnipod® product platform. Our technology provides wearable, waterproof, and lifestyle-accommodating insulin delivery systems that empower patients to live healthier lives.