Global Product Monitoring Vigilance Report Writer

Are you an experienced Medical Device Vigilance or Pharmacovigilance professional looking to broaden your international exposure?We are seeking a Post Market Surveillance & Vigilance Specialist to support global patient safety activities across multiple markets. This role offers the opportunity to work with cross-functional teams worldwide, contributing to complaint handling, adverse event reporting, post-market surveillance activities, trend analysis, regulatory compliance, and continuous improvement initiatives. This is an excellent opportunity for someone who enjoys combining technical vigilance expertise with global stakeholder engagement in a growing, highly regulated environment.What You'll Do

• Manage and support complaint handling and post-market surveillance activities across international markets.
• Review and investigate adverse events and product complaints.
• Assess reportability and prepare vigilance submissions in accordance with applicable regulatory requirements.
• Support Medical Device Reporting (MDR) and other global vigilance obligations.
• Analyse complaint, reliability and product performance data to identify trends and potential safety signals.
• Conduct device history record reviews and support investigations into product issues.
• Partner with Quality, Regulatory Affairs, Customer Care, Manufacturing and Engineering teams globally.
• Contribute to audit readiness and support inspections conducted by regulatory authorities and notified bodies.
• Develop reports, dashboards and documentation to support compliance and decision-making.
• Provide training and guidance to colleagues on complaint and vigilance processes., Work with stakeholders across Europe, North America and other global markets.
• Contribute directly to patient safety and product quality.
• Expand your international regulatory and vigilance expertise.
• Be part of a collaborative, mission-driven environment committed to improving lives.
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.


• Experience within medical device vigilance, post-market surveillance, complaint handling, product safety or pharmacovigilance.
• Strong understanding of MDR vigilance requirements and adverse event reporting processes.
• Experience assessing reportability and preparing regulatory submissions.
• Ability to interpret and analyse safety, complaint or reliability data.
• Strong written communication skills, including technical and regulatory writing.
• Experience working within regulated healthcare, medical device, pharmaceutical or life sciences environments.
• Ability to collaborate effectively with international stakeholders., EU MDR, UK MDR or global vigilance reporting.
• International market exposure.
• Complaint investigation and trend analysis.
• Medical device quality systems (ISO 13485) or equivalent.
• FDA reporting or global post-market surveillance programmes., 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!