Risikomanager Medizintechnik (m/w/d)
Hybrid
Core
Application and responsibility of the Safety Risk Management process according to ISO 14971 for medical devices in the Patient Interfaces area.
Role type
Risk Manager for Medical Devices
Builds
Risk Management Files for new developments and maintenance of the existing portfolio
Domain
Medical Devices / Patient Interfaces
Required skills
ISO 14971, risk analysis, change management, CAPA handling, complaint management, process development
Preferred skills
Security Risk Management
Technologies
ISO 14971
Responsibilities
Coordinate and create Risk Management Files for new developments, maintain the existing portfolio in the context of Change Management, organize and moderate regular analysis rounds, analyze and strategically develop the existing process landscape
Seniority
Mid-level, hands-on IC