Junior Expert Regulatory Information Management
vor 3 Wochen
**Your assignments**:
- Creation and provision of regulatory documents for the global registration of FME medical devices
- Provision of certificates (EU, EC, ISO)
- Creation and update of templates in responsibility of the Regulatory Information Management (RIM) team
- Coordination of notarization (notary, court, consulate, embassies, etc.) of documents required for global registrations (declarations, letters of confirmation, LoAs/PoAs etc.)
- Support for implementation and maintenance of a registration information management system (RIMS)
- Consulting and supporting all involved parties in the global registration of FME medical devices to ensure timely access to all relevant markets
- Planning, documenting, monitoring, reporting and tracking of projects in the RIM area
**Your profile**:
- University Degree (minimum Bachelor) in Engineering or Natural Science or comparable education
- Professional experience in the medical device industry in the area of quality management or regulatory affairs is an advantage
- Professional experience in internationally acting companies is an advantage
- Expertise in medical device regulations and required processes
- Knowledge in applicable quality management standards
- IT-skills in MS Office and RIMS Software
- Fluent in Business English
- Willingness to travel
**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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