Archiviertes Projekt - Labelling Specialist (m/f/d)

Ihre Aufgaben:
• Updating the product labels and related documentation to fulfill the Regulation (EU) 2017/746 (MDR)
• Manages the product labeling process, creates and approves the individual labels
• Close collaboration with the Manufacturing, R&D, Quality and Regulatory Affairs
• Establishment and improvement of the labeling process
• Participating in cross-functional and cross-business area project teams
• Support external audits/inspections
• Lead and/or support different activities for the EU MDR implementation
• Perform other duties and projects as assigned
• Creating, updating, and maintaining labeling records throughout the life of a product.
• Ensure the products meet regulatory labeling requirements for international distribution.

Ihre Qualifikationen:
• Strong experience in matter of quality assurance for products (class I, IIa/IIb). Class III would be an advantage.
• Knowledge and working experience of quality management system, standards and government regulations applicable to medical devices e.g. ISO 13485, 21 CFR 820 QSR, MDD 93/42/EEC, MDSAP, ISO 14971, and ISO 15223. 
• Regulation (EU) 2017/746 is an advantage
• Analytical and structured working style; strong attention to detail
• Ability to effectively work as part of a multidisciplinary, international team. Good team working skills
• Fluent in German and English
• Hands-on personality, with flexibility and dedication to maximize our client's value
• Experience in working in a highly regulated environment
• University degree in Engineering, Life science or related fields
• Work experience in the Medical Device Business (QARA), with cross-functional experience in international environment.

Ihre Vorteile:
• You will work in an international environment
• Varied tasks in a renowned company

Projektdauer: 6 MM


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