Quality & Regulatory Affairs EMEA
Core
Ensuring compliance, supporting product readiness, and delivering trusted healthcare solutions across EMEA by managing quality and regulatory operations.
Role type
Senior IC Quality & Regulatory Affairs Manager
Builds
EMEA-wide Quality Management System, compliant product launches, and regional regulatory adherence
Domain
Healthcare / Medical Devices / Pharmaceuticals
Deliverable
client delivery
Required skills
Quality Management, Project Management, Medical Device regulations, Pharmaceutical regulations (GDP), ISO 13485, GDP, MDR, IVDR, ISO 13485:2016, Risk management (FMEA), Computerized systems validation, Gap analysis, CAPA management, Policy documentation, Regional coordination
Preferred skills
Life Sciences degree, Pharmacist license, Biomedical Engineering background
Technologies
None explicitly stated
Responsibilities
Document EMEA policies and implement the Quality Management System; Manage daily operations, communication, and regional quality projects; Perform quality and regulatory visits/audits and ensure CAPA follow-up; Organize regional meetings and track action items; Support the PRRC of the EC Rep in Germany regarding Quality Agreements; Support the Spanish QA/RA Team on GDP and MDR compliance
Seniority
Senior, hands-on IC with strategic oversight
