Overview In this role you will support CE marking for IVD devices by managing schemes, delivering expert technical reviews, and guiding QMS and regulatory activities. You’ll mentor healthcare personnel and collaborate with the commercial team to
Overview In this role you will lead CDx regulatory strategy for pharmaceutical, biotech, and diagnostic programs. You will partner with cross-functional teams to align diagnostic development, biomarker strategy, and clinical trial plans with regulatory expectations and commercialization goals.
Overview In this role you will lead CDx regulatory strategy for pharmaceutical, biotechnology, and diagnostic clients, translating global requirements into practical plans. You will shape regulatory pathways for companion diagnostics and clinical trial assays, aligning biomarker strategies with