Manager, E.U. Medical Device & IVD Regulation
Core
Subject matter expert for EU Medical Device and In Vitro Diagnostic Regulations, ensuring effective integration within the Clinical Quality Management System (QMS) and leading regulatory impact assessments.
Role type
Manager, Regulatory Compliance (Medical Devices & IVD)
Builds
Regulatory compliance frameworks and QMS processes for global clinical development of medical devices, diagnostics, and combination products.
Domain
Healthcare / Medical Devices / In Vitro Diagnostics / Regulatory Affairs
Required skills
EU MDR, EU IVDR, FDA medical device regulations, regulatory impact assessments, gap analyses, risk evaluations, QMS controls, cross-functional project leadership, change management
Preferred skills
Combination product development, GCP, ICH guidelines, health authority inspections, CAPA programs, intelligent automation
Technologies
Microsoft Office
Responsibilities
Monitor and assess new EU MDR/IVDR regulations and standards; Lead regulatory impact assessments including gap analyses and risk evaluations; Drive updates to QMS processes, SOPs, and training programs; Support audits, inspections, and continuous improvement initiatives.
Seniority
Manager, hands-on IC
