Medical Device Compliance Expert Dialyzers and

vor 2 Wochen

Sankt Wendel, Deutschland Fresenius Medical Care Vollzeit

**Your assignments**:

- Creation and maintenance of the technical documentation for the implementation of new regulatory requirements (MDR)
- Interface to development, marketing, regional/local approval units and other superordinated functions
- Conducting and supporting regulatory activities to maintain regulatory compliance
- Regulatory support for change projects
- International coordination and communication

**Your profile**:

- Successfully completed technical or scientific studies (master or diploma)
- Experience in regulatory affairs or in a quality environment, ideally in the pharmaceutical/medical environment
- Further knowledge of the relevant medical device regulations (MDD 93/42/EEC, MDR 745/2017, NMPA, MDSAP, US FDA etc.)
- Fluent knowledge of English
- Structured and independent way of working
- Strong communication skills
- Enthusiasm
- Assertiveness

**Our offer to you**:
There is a lot for you to discover at Fresenius, because we have a lot to offer. No matter in which field you are an expert (M/F/d) and how much experience you bring with you - for your professional future with meaning:

- The opportunity to work on a mobile basis, individually in consultation with your manager
- Whether in front of or behind the scenes - you will help to make better and better medicine available to more and more people around the world
- Individual opportunities for self-determined career planning and professional development
- A corporate culture in which there is enough room for innovative thinking - to find the best, not the fastest, solution together
- A large number of committed people with a wide range of skills, talents and experience
- The benefits of a successful global corporation with the collegial culture of a medium-sized company

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