Skills: Regulatory Affairs, Labeling, Medtech
- Create, update, and maintain labelling records throughout the life of a product
- Manage Supplier labels, quality checks, evaluations and agreements
- Ensure that the products meet regulartory labeling requirements for international distribution
- Strong experience in matter of labelling for products (class I, IIa/IIb).
- Knowledge and working experience of quality management system, standards and regulations applicable to medical devices e.g. ISO 13485, 21 CFR 820 QSR, MDR, ISO 15223-1, ISO 20417:2021, ISO 14971, IEC 60601-1
- Strong experience in Supplier Management