Global Product Monitoring Vigilance Report Writer
On-siteLondon, England, United Kingdom
Job Summary
Manage and support complaint handling and post-market surveillance activities across international markets by reviewing adverse events, assessing reportability, and preparing vigilance submissions in accordance with regulatory requirements. Analyze complaint, reliability, and product performance data to identify trends and potential safety signals while conducting device history record reviews and supporting investigations into product issues. Partner with Quality, Regulatory Affairs, Customer Care, Manufacturing, and Engineering teams globally to contribute to audit readiness and support inspections. Develop reports, dashboards, and documentation to support compliance and decision-making, and provide training and guidance to colleagues on complaint and vigilance processes. This role offers the opportunity to work with cross-functional teams worldwide, contributing to continuous improvement initiatives within Insulet's Omnipod product platform.
Required Qualifications
- 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
Desired Qualifications
- Experience 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
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