Quality & Regulatory Affairs EMEA
Core
Partner across EMEA countries to ensure compliance, support product readiness, and deliver trusted healthcare solutions through Quality & Regulatory Affairs operations.
Role type
Regional Quality & Regulatory Affairs Manager
Builds
EMEA-wide Quality Management System, regulatory compliance for medical devices and pharmaceuticals
Domain
Healthcare / Medical Devices / Pharmaceuticals
Required skills
Quality Management, Project Management, Medical Device regulations, Pharmaceutical regulations, GDP, MDR, ISO 13485, CAPA management, Audit support, Risk management, Validation of computerized systems
Preferred skills
FMEA, PRRC support experience, Spanish QA/RA team collaboration
Technologies
ISO 13485:2016, MDR, IVDR, GDP, ISO 13485
Responsibilities
Document EMEA policies and implement Quality Management System, manage regional quality projects and reporting, perform and support audits and gap analysis, organize regional meetings, drive EMEA-wide initiatives, support PRRC and Spanish QA/RA teams
Seniority
Senior, hands-on IC with strategic oversight