At Medtronic, I support the EU MDR Program and global replenishment of MDR-approved medical devices. I verify regulatory data, track submission timelines, and maintain records and correspondence for document control and audit readiness.
As a Biocompatibility Specialist / Project Coordinator, I supported post-market compliance by coordinating testing and documentation for EU MDR submissions. I also developed Power BI dashboards to analyze testing timelines and report progress.
At Abbott, I managed document and change control activities for post-market submissions and tracked complaint-related documentation in SAP and Windchill. Earlier, at Millipore Sigma, I created hazard assessments and safety documentation and contributed to audit readiness.
