Regulatory Affairs in the field of Labelling
Company
The client company is a globally active medical technology company with a focus on the development, manufacture and marketing of medical technology products in the field of traumatology and orthopedics.
Area of expertise
Regulatory Affairs
Project tasks
- Process optimization in the area of labeling (labels and instructions for use)
- Process description as well as optimization of all processes and interfaces (areas of responsibility, release, etc.)
- Utilization of optimization possibilities through modularization and grouping
- Coordination and cooperation with internal interfaces: Validation, QM, product management, R&D
- Support in the correct creation of product labels, instructions for use, IFUs according to EU MDD/MDR and international requirements
- Coordination of external translation agencies
Project duration
- 3 months
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