QMB (m/w/d) für unser Qualitätsmanagement (ISO 13485) in Kombination mit Regulatory Affairs Aufg
On-site
Core
Maintaining and developing the ISO 13485 quality management system and handling regulatory affairs tasks for medical device development and production.
Role type
Quality Management and Regulatory Affairs Specialist
Builds
Medical devices for physical therapy
Domain
Medical technology / Regulatory compliance
Required skills
ISO 13485 knowledge, Medical device regulation knowledge, Technical documentation creation, Audit preparation and execution, Structured work approach, Communication skills
Preferred skills
Regulatory environment knowledge, Quality management ISO 13485 knowledge
Technologies
ISO 13485, MDR 2017/745
Responsibilities
Maintain and develop the ISO 13485 quality management system, Prepare and conduct internal and external audits, Create and maintain technical documentation according to MDR 2017/745