Sr Manager, Quality and Regulatory Operations
Core
Lead regulatory and quality operations to ensure medical device products, processes, and documentation meet EU and global requirements, supporting compliance, market access, and commercial success.
Role type
Senior Manager, Quality and Regulatory Operations
Builds
Regulatory compliance, market access readiness, and operational excellence for medical devices
Domain
Medical device industry, European regulatory frameworks
Required skills
EU MDR (2017/745) expertise, EUDAMED management, UDI framework implementation, Quality Management Systems (ISO 13485), CAPA, change control, audit readiness, regulatory gap assessment
Preferred skills
Patient monitoring domain knowledge, digital health/software-enabled medical technologies, 3-5+ years people leadership, matrix leadership experience, multi-country quality and regulatory operations
Technologies
EUDAMED, UDI frameworks, QMS tools
Responsibilities
Lead RA/QA operations strategy and execution, drive regulatory and quality support for tenders, oversee EUDAMED compliance, support UDI framework implementation, manage and improve QMS processes
Seniority
Senior, hands-on IC with people leadership