VP, Post Market Surveillance

Insulet Corporation•Acton, MA

About The Position

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. 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.

Requirements

Bachelor’s degree in Engineering, Life Sciences, or related discipline required
15+ years in medical device quality, regulatory affairs, or post‑market surveillance
7–10+ years in senior, enterprise‑level leadership roles with global scope
Demonstrated success leading large, complex, regulated organizations through growth and change
Deep expertise in FDA post‑market surveillance, EU MDR compliance, ISO 13485, ISO 14971
Experience with software‑enabled, connected, or digital health medical devices
Able to translate technical complexity into executive‑level decisions

Nice To Haves

Advanced degree (MS, PhD, MD, PharmD) preferred

Responsibilities

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.
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.
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.
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 Authority interactions related to PMS.
Lead regulatory responses, commitments, and remediation with a focus on credibility, speed, and sustainable resolution.
Oversee enterprise signal detection, trending, and escalation across complaints, adverse events, returned product investigations, real‑world evidence, clinical follow‑up, and digital health data.
Chair or sponsor benefit‑risk evaluations impacting global safety decisions and product strategy.
Ensure proactive updates to Risk Management Files (ISO 14971), Clinical Evaluation Reports, and benefit‑risk documentation.
Be a visible champion of patient‑centric decision‑making, even under commercial or operational pressure.
Oversee PMS systems, vigilance databases, analytics platforms, and EUDAMED readiness with strong data integrity and traceability.
Advance digital, data‑driven surveillance capabilities aligned with software‑enabled, connected, and algorithm‑driven therapies.
Ensure PMS functions support real‑world evidence strategies and evolving regulatory expectations.