
Dr. Daria Radchenko
Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von Daria Radchenko
- Current 3 years and 5 months, since Jan 2023TÜV SÜD Product Service GmbH
Lead Auditor (non-active medical devices)
- QMS and regulatory auditing of non-active medical device manufacturers (ISO 13485, MDD, MDR, MDSAP, Taiwan) - Technical documentation assessment for substance based medical devices - Project management for QMS certification - Development of internal training materials
- 1 year and 6 months, Jul 2021 - Dec 2022TÜV SÜD Product Service GmbH
Auditor (non-active medical devices)
- 1 year, Jul 2020 - Jun 2021
Team Lead Regulatory Affairs
bitop AG
Regulatory Affairs in the field of substance based drug-like medical devices class I/IIa (MDD) or IIa/IIb (MDR) - Strategic planning for MDD-to-MDR transition - International medical device registration (EU, CIS, ASEAN, MENA, USA, Australia) - Regulatory supervising of internal and customer-specific product development projects - Deputy Safety Officer
- 1 year and 1 month, Jun 2019 - Jun 2020
Junior Regulatory Affairs Manager
bitop AG
Research and teaching activities in the field of molecular biology and genetics of lower procaryotes (fungi).
- Cultivation and genetic modification of E. coli, yeast and filamentous fungi - Purification and identification of biomolecules - Investigation of cellular signaling pathways / phosphorylation cascades - Microscopy imaging - Assissting in molecular biology basic lab course and botany lectures.
Quality Control: Physical, chemical and microbiological testing of semi-finished and finished food products; incoming inspection of food raw materials.
Ausbildung von Daria Radchenko
- 4 years and 2 months, May 2014 - Jun 2018
Molecular Biology
Ruhr-Universität Bochum
PhD Thesis: "Cellular signaling pathways in the filamentous fungus Sordaria macrospora: Molecular genetic analysis of the STRIPAK-associated germinal center kinase SmKIN3 in developmental processes"
- 4 years and 9 months, Sep 2007 - May 2012
Biology
Donetsk National University
Sprachen
Ukrainian
C2 (Verhandlungssicher / Muttersprachlich)
Russian
C2 (Verhandlungssicher / Muttersprachlich)
Spanish
A1-A2 (Grundkenntnisse)
English
C1 (Fließend)
German
C1 (Fließend)
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