VP, Post Market Surveillance at Insulet Corporation in Acton, MA

VP, Post Market Surveillance Location: US - Massachusetts (Acton - Office) 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 Authority interactions related to PMS. Lead regulatory responses, commitments, and remediation with a focus on credibility, speed, and sustainable resolution. Safety Signal Leadership & Benefit‑Risk Governance 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. Digital, Data & Future‑Ready Surveillance 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. Leadership Profile & Capabilities (What “Great” Looks Like) Enterprise Leadership & Presence Operates comfortably at the C‑suite and Board level with strong executive presence and judgment Demonstrated ability to influence without authority and lead through complexity Builder & Scaler Proven experience designing organizations, processes, and governance models that scale globally Track record of simplifying complex regulatory environments into clear operating models People Developer Known for developing leaders, not just managing teams Creates accountability, psychological safety, and high standards simultaneously Technical Credibility (Foundation, Not the End State) 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 Education & Experience Bachelor’s degree in Engineering, Life Sciences, or related discipline required Advanced degree (MS, PhD, MD, PharmD) preferred 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 Additional Information: Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $0.00 - $0.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: • Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education. Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com. We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it! At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. (Know Your Rights)