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Juliane Kuhtz, Dr

Manager Regulatory Affairs
Fresenius Kabi Deutschland GmbH

Dr. Juliane Kuhtz, Manager Regulatory Affairs, Fresenius Kabi Deutschland GmbH

Expertise
o Responsible for the maintenance and new creation of the Technical Documentation of Medical Devices, ensuring MDR (EU) 2017/745 compliance; regulatory-related actions during change process and development of new products; Portfolio: CE-labeled products for the product groups of Medical Devices related to enteral nutrition application
o Responsibility and collaboration during generation of Biocompatibility acc. ISO 10993-1
o Responsibility and collaboration during generation of Clinical Evaluations acc. MEDDEV 2.7.1

Professional development
Since 01/03/2019 Manager Regulatory Affairs, Fresenius Kabi Deutschland GmbH, Bad Hersfeld
16/11/2016- 28/02/2019 Junior Manager Regulatory Affairs, Fresenius Kabi Deutschland GmbH, Bad Hersfeld
15/04/2016 –15/10/2016 Regulatory Affairs Specialist, Bio-Rad Medical Diagnostics GmbH, Dreieich
30/11/2015 – 14/04/2016 Trainee Life Science Management, ATV GmbH, Munich
10/2010 – 03/2015 Research Assistant, Julius-Maximilians University of Würzburg, Institute for Human Genetics, Prof. Dr. Thomas Haaf
10/2009 – 09/2010 Research Assistant, Imperial College London, Heart Science Centre Harefield, UK, Prof. Dr. Thomas Brand
04/2009 – 09/2009 Research Assistant, Julius-Maximilians University of Würzburg, Institute of Zoology Cell and Developmental Biology, Prof. Dr. Thomas Brand

Education
10/2010 – 12/2014 PhD study biology, Julius-Maximilians University of Würzburg, Institute for Human Genetics, Prof. Dr. Thomas Haaf, Topic: “Epimutations of human germ cells and infertility“, 03/2015 graduation
04/2009 –09/2010 PhD study biology, Julius-Maximilians University of Würzburg / Imperial College London - Heart Science Centre Harefield, UK, Prof. Dr. Thomas Brand, Topic: “Genetic and biochemical analysis of the structure-function relationship of the Popdc family”
10/2002 –12/2008 Study of Biology (Diploma), Julius-Maximilians University of Würzburg, Major subject: Neurobiology; Minor subjects: Cell and Developmental Biology, Human Genetics, Biochemistry, Diploma work topic: “Structure function analysis of the Popeye domain of the Popdc1 protein in mice: site-directed mutagenesis, cAMP binding and phenotypic characterization”
1996 – 2002 Gymnasium “Albert Einstein“ in Magdeburg; Degree: Abitur

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