VP, Post Market Surveillance

 Company Overview

Insulet started in 2000 driven to achieve our mission of enabling our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients who have insulin-requiring diabetes, by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are on an exciting trajectory of significant growth and global expansion enabling us to reach more patients around the globe.

We are looking for highly motivated, performance driven individuals who want to be part of building our Center of Excellence and be at the forefront of our rapidly growing global footprint. We are looking to hire amazing people who are guided by shared values and desire to exceed customer expectations. Our continued success depends on it.

Position Overview

The Vice President, Post-Market Surveillance (PMS) is a mission‑critical enterprise leadership role with accountability for global post‑market surveillance, patient safety, and product performance across Insulet’s full ecosystem of insulin delivery systems, software, algorithms, and digital health platforms.

The VP, Post-Market Surveillance is expected to operate as a trusted enterprise leader, Board‑facing advisor, and culture carrier for quality, compliance, and patient safety. Beyond technical excellence, this leader will build, scale, and future‑proof global teams, leaders, and end‑to‑end processes to support Insulet’s continued innovation and rapid global expansion.

The role reports to the SVP, Quality, Regulatory Affairs & Compliance and serves as a core member of the extended Quality & Compliance leadership team.

Executive Scope & Impact

This leader owns the strategic vision, operating model, and organizational maturity of Insulet’s Post-Market Surveillance capability, ensuring:

• World‑class patient safety oversight and benefit‑risk governance

• Sustainable global regulatory compliance in FDA, EU MDR, and emerging markets

• Scalable, inspection‑ready systems and processes

• Strong leadership bench and succession planning within Quality & Compliance

• Enterprise confidence in decision‑making during high‑risk events

Key Responsibilities

Enterprise & Strategic Leadership

• Serve as the executive owner of global Post‑Market Surveillance (PMS), providing vision, strategy, and long‑term roadmap aligned to Insulet’s growth, pipeline, and digital future.

• Act as a senior advisor to executive leadership and the Board on patient safety, post‑market risk, regulatory exposure, and benefit‑risk strategy.

• Operate with an enterprise quality mindset, demonstrating enterprise judgment, accountability, and decision authority expected of a future C‑suite leader.

• Establish governance models that ensure clarity of ownership, escalation, and executive decision‑making across regions and functions.

Organizational Leadership, Team Building & Succession

• Build, scale, and inspire a high‑performing global organization, including regional and functional leaders across PMS, vigilance, analytics, and digital surveillance.

• Develop next‑generation leaders capable of enterprise influence, regulatory credibility, and independent decision‑making.

• Implement clear operating rhythms, leadership expectations, and performance management aligned with Insulet’s values and growth trajectory.

• Create a sustainable succession pipeline within Product Monitoring and the broader Quality & Compliance function.

Process Architecture & Operating Model Excellence

• Design and continuously evolve a globally harmonized, scalable PMS operating model that is inspection‑ready by design.

• Serve as QMS process owner for Post‑Market Surveillance, Vigilance, Market Surveillance, and related management review inputs.

• Drive simplification, standardization, and automation of core processes to support scale without increased risk.

• Ensure end‑to‑end integration of PMS outputs into CAPA, Risk Management, Design Controls, Labeling, Training, and Product Strategy.

Global Regulatory & Compliance Leadership (Technical Depth Anchored by Judgment)

• Maintain executive accountability for FDA MDR, EU MDR Vigilance, PMCF, PSURs, Trend Reporting, and evolving global post‑market requirements.

• Act as executive authority and primary leader for FDA inspections, EU Notified Body audits, and Competent