Global Product Monitoring Vigilance Report Writer (Remote)

📋 Description

• • The Global Product Monitoring Vigilance Report Writer plays a critical role in ensuring patient safety and regulatory compliance by managing post-market vigilance activities for Insulet’s medical devices, directly supporting the company’s mission to improve lives of people with diabetes through timely and accurate reporting of adverse events to global health authorities.
• • This role is essential for maintaining Insulet’s quality management system integrity, enabling proactive risk identification, and upholding the company’s reputation for excellence in medical device safety and regulatory adherence across international markets.
• • Responsible for the end-to-end assessment, follow-up, coding, and vigilance activities for complaints received globally, ensuring each case is thoroughly evaluated and processed in accordance with internal procedures and external regulatory expectations.
• • Author, peer review, and approve vigilance reports to guarantee on-time submission to appropriate regulatory authorities, including the FDA, EMA, and other national competent authorities, while maintaining meticulous documentation and traceability.
• • Support day-to-day operations in a fast-paced environment by assisting management with complaint triage, ensuring proper coding of reportable events, and facilitating timely escalation when necessary to meet regulatory timelines.
• • Collaborate cross-functionally with engineering, complaint investigation laboratory, medical affairs, and quality teams to review event details, investigation outcomes, and root cause analyses, ensuring alignment between technical findings and regulatory reporting obligations.
• • Contribute to the department’s non-conformance management by identifying trends and escalating relevant issues into the CAPA (Corrective and Preventive Action) system to drive continuous improvement in product safety and quality.
• • Serve as a subject matter expert for internal and external stakeholders on post-market surveillance, complaint handling, and regulatory requirements, providing guidance during audits, inspections, and ad-hoc inquiries from regulatory bodies or internal teams.
• • Assist with special projects as assigned, including process improvements, system validations, and regulatory readiness initiatives, operating with minimal supervision and demonstrating initiative and ownership.
• • About the team or company: Insulet Corporation is a pioneering medical device company headquartered in Massachusetts, dedicated to transforming diabetes care through its innovative Omnipod Insulin Management System, which delivers tubeless, wearable insulin delivery for up to three days without needles or multiple daily injections.
• • The company’s flagship Omnipod 5 Automated Insulin Delivery System integrates with continuous glucose monitors to enable automated insulin dosing, eliminating fingersticks and offering smartphone-controlled therapy, reflecting Insulet’s commitment to advancing patient-centric, technology-driven solutions in diabetes and beyond.
• • What the person can learn or achieve in this role: Develop deep expertise in global medical device vigilance regulations, including MDR, 21 CFR Part 803, and country-specific reporting requirements, positioning yourself as a trusted authority in post-market safety compliance.
• • Gain hands-on experience influencing cross-functional teams without direct authority, refining your ability to drive quality outcomes through collaboration, data-driven persuasion, and expert communication in a high-stakes, regulated environment.