In your role as Change Management Specialist (m/f/d) you are responsible for assessing design and process changes according to local requirements to ensure regulatory product availability on global markets.
Your assignments
- Maintain criteria applying to regulatory pre-assessments for the evaluation of potential impact on international registrations of medical devices
- Perform regulatory pre-assessments on design and process changes
- Initiate local change evaluation (regulatory assessments in the countries/ regions) as appropriate
- Monitor local feedback regarding regulatory impact and communicate results to change responsibles/ project leaders
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Your profile
- Completed studies in a scientific/technical field or comparable training with professional experience
- First professional experience in the field of Regulatory Affairs, Quality Management, Change Control or other related Research and Development functions
- Technical knowledge as well as quick comprehension and perceptiveness
- Very good English skills (written and spoken)
- Familiarity with MS Office
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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