Beschreibung
Labelling Specialist (m/f/d)
Reference: -en
Start: asap
Duration: 6 MM
Main tasks:
- Updating the product labels and related documentation to fulfill the Regulation (EU) (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.
Main qualifications
- 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) 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.
Main advantages:
- You will work in an international environment
- Varied tasks in a renowned company
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
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