Manager, QARA Benelux & Nordics
Core
Provide operational leadership for quality assurance and regulatory affairs across Benelux and Nordic markets to ensure compliance, manage risk, and support market access for orthopedic devices.
Role type
Manager, Quality Assurance & Regulatory Affairs (QARA)
Builds
Regulatory compliant orthopedic device portfolios in Benelux and Nordic markets
Domain
Medical Devices / Orthopedics / Healthcare
Required skills
EU MDR knowledge, product lifecycle management, regulatory submissions, stakeholder management, audit/inspection coordination, policy analysis
Preferred skills
Multi-country portfolio experience, process improvement, post-market surveillance, RAC certification
Technologies
None stated
Responsibilities
Lead QARA activities for product registrations and renewals; Ensure compliance with EU MDR and local regulations; Coordinate regulatory submissions and health authority responses; Partner with cross-functional teams for business objectives; Monitor regulatory changes and assess operational impacts; Support regulatory inspections and audits; Contribute to regional policy initiatives
Seniority
Manager, operational leadership