Quality and Regulatory Affairs Manager Medical Devices (m/f/d)
Core
Ensuring regulatory compliance and quality management for medical devices through gap analyses, technical documentation, and risk management.
Role type
Manager, Quality and Regulatory Affairs
Builds
Market access strategies, compliant technical documentation, and robust Quality Management Systems (QMS)
Domain
Medical Devices / Regulatory Affairs / Quality Management
Required skills
Regulatory gap analysis, Technical documentation creation, Market access strategy, QMS establishment, Risk management, Safety assessment
Preferred skills
German language proficiency, Experience with hardware/software/mechanics systems
Technologies
MDR, IVDR, ISO 13485, ISO 14971, IEC 62304, FMEA, FTA
Responsibilities
Conduct regulatory GAP analyses, Create and maintain technical documentation, Develop market access and registration strategies, Establish and improve Quality Management Systems, Monitor global regulatory developments, Lead risk identification and analysis, Assess safety relevance of hazards
Seniority
Manager, hands-on IC