0Regulatory Affairs Clinical Writing Professional (m/f/d)
Fresenius Kabi Deutschland GmbH | Germany | 36xxx Bad Hersfeld | Permanent position | Full time | Published since: 24.04.2026 on stepstone.de

Regulatory Affairs Clinical Writing Professional (m/f/d)


Our aim is to provide medical professionals with the best possible solutions to find the right answer for any challenge. Fresenius Kabi is a pioneer in health for the coming decade. We live diversity and appreciate different personalities and attitudes.

Traditional sense of Fresenius

Fresenius employs around 190,000 people around the world who are committed to getting more and more people access to better and better medicine. In international teams we work to improve the lives of sick people. Regardless of the area in which the Group operates, our employees convey the meaning of our common endeavour and action: for themselves, for the patients and for Fresenius. Our work saves life and makes extraordinary health care reality.

Fresenius Kabi is a globally active healthcare company that offers medicines and medical devices for infusion, transfusion and clinical nutrition. Our products and services are used in the therapy and care of critical and chronically ill patients. As Regulatory Affairs Clinical Writing Professional, you play a key role in the clinical evaluation and clinical-regulatory documentation of our medical devices. They actively shape the entire product life cycle – from the planning of clinical evaluations, the creation of central documents to the post-market-surveillance. Your work directly contributes to ensuring the safety, performance and regulatory compliance of our products worldwide. .

Your tasks • Your profile • What we offer

Create and update clinical reviews over the entire product lifecycle Ensure regulatory requirements (EU MDR, FDA) Develop study protocols incl. Entry/exclusion criteria, endpoints and methods, if necessary Interdisciplinary cooperation with R&D, RA, QA and marketing Conduct literature research and data analysis for clinical evidence Conduct risk assessments and integrate them into clinical assessment Support Post-Market-Surveillance (PMS-Pläne, PSURs, PMCF, Trend Analyses)

Completed scientific studies (medicine, biomedical engineering, natural sciences, etc.) Knowledge of clinical research and regulation in medical devices Experience with statistical evaluations and clinical evaluation methods Strong project management and communication skills Independent, structured and reliable operation Team skills in interdisciplinary and international environments High detail accuracy and quality awareness

Location

ava Fresenius Kabi Deutschland GmbH
36251  Bad Hersfeld
Germany

The text of this ad was translated from German into English using an automatic translation system and may contain semantic and lexical errors. Therefore, it should be used for introductory purposes only. For more detailed information, see the original text of the ad at the link below.

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