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Regulatory Affairs Labeling Specialist (m/w/d) (DE)
[12972]
Regulatory Affairs, Labeling, Medtech
Job title: Regulatory Affairs Labeling Consultant (m/w/d) Industry: Medizintechnik Skills: Regulatory Affairs, Labeling, Medtech Start of project: ASAP Duration of the project : 5 Monate Project volume: 600 Stunde(n) Location: Zürich, Schweiz Tasks: §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 Qualifications: §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
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
Minette Potger