Risk Manager Medical Devices (m/w/d)
Core
Ensure patient safety and product performance across the entire lifecycle of medical devices by managing risks and ensuring regulatory compliance.
Role type
Senior Risk Manager (Medical Devices)
Builds
Risk management strategies and compliance frameworks for medical devices
Domain
Medical Devices / Regulatory Affairs
Required skills
ISO 14971 risk management, regulatory compliance, stakeholder advisory, process development, documentation management, project coordination
Preferred skills
IEC 60601-1, IEC 80002-1
Technologies
ISO 14971, IEC 60601-1, IEC 80002-1
Responsibilities
Identify, assess, and monitor risks according to ISO 14971; ensure compliance with international regulations; advise internal departments on risk minimization and damage limitation; communicate risks and developments to management; support management reviews and maintain risk management files; accompany projects and product adaptations regarding regulatory and clinical requirements.
Seniority
Senior, hands-on IC