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, compliant product launches, and regulatory reporting for medical devices and pharmaceuticals.
Domain
Healthcare (Medical Devices & Pharmaceuticals) in EMEA
Deliverable
client delivery
Required skills
Quality Management, Project Management, Medical Device regulations, Pharmaceutical regulations (GDP), ISO 13485:2016, GDP, MDR, IVDR, ISO 13485, Risk management (FMEA), Computerized systems validation, Gap analysis, CAPA management, Audit support, PRRC support, Quality Agreements review.
Preferred skills
None explicitly stated as preferred (listed as 'plus' in requirements but mapped to required skills above for clarity).
Technologies
None explicitly stated (FMEA and computerized systems validation mentioned as knowledge areas).
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 issue gap analysis; follow up on CAPA; organize regional meetings; drive EMEA-wide QA/RA initiatives; support the PRRC of the EC Rep in Germany; support the Spanish QA/RA Team for compliance.
Seniority
Manager, regional oversight & execution