Senior Quality Systems Engineer (Medical Devices)

Katalyst CRO is seeking a Quality/Regulatory Compliance professional to ensure QMS alignment with FDA 21 CFR Part 820, ISO 13485, EU MDR, and related standards. The role focuses on harmonizing local QMS across sites, implementing procedures, and ensuring regulatory conformance for medical devices including SaMD and class II devices. Strong collaboration with R&D and Regulatory is essential.