Senior Specialist, Quality & Regulatory Affairs

In this role you will support Quality & Regulatory compliance for the Netherlands and broader Europe, focusing on Economic Operator obligations under EU law. You will maintain and improve QMS processes to back the Commercial organization, and serve as an SME for EO requirements across Europe, with initial emphasis on IVDR and MDR. The role involves collaborating with regulatory and COE teams to ensure importer/distributor obligations are met and EO processes are sustainable. You will be part of a global diagnostics team that accelerates innovation and improves patient outcomes.