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).
Role type
Manager, Regulatory Compliance (Medical Devices & IVD)
Builds
Regulatory compliance frameworks and QMS processes for global clinical development programs
Domain
Healthcare / Medical Devices / In Vitro Diagnostics / Regulatory Affairs
Required skills
EU MDR/IVDR regulation expertise, FDA medical device regulations knowledge, QMS process design, regulatory impact assessment, cross-functional project leadership, risk management
Preferred skills
Combination product development, GCP/ICH guidelines, health authority inspection support, intelligent automation, data-driven quality solutions
Technologies
Microsoft Office, digital quality tools
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 CAPA initiatives
Seniority
Manager, hands-on IC
