Dr. Daria Radchenko

Angestellt, Lead Auditor (non-active medical devices), TÜV SÜD Product Service GmbH
Abschluss: Dr. rer. nat., Ruhr-Universität Bochum
Bern, Switzerland

Fähigkeiten und Kenntnisse

Quality Management
Regulatory Affairs
Compliance
Medical Devices
Biotechnology
Auditing
Scientific Writing
Research
ISO 13485
MDSAP
MDR
Risk Management
ISO 14971
Biocompatibility
ISO 10993
Borderline Products
OTC
Positive attitude
self-management
Commitment
Creativity

Werdegang

Berufserfahrung von Daria Radchenko

  • Current 3 years and 5 months, since Jan 2023

    Lead Auditor (non-active medical devices)

    TÜV SÜD Product Service GmbH

    - 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 2022

    Auditor (non-active medical devices)

    TÜV SÜD Product Service GmbH
  • 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

  • 8 months, Aug 2018 - Mar 2019

    Postdoctoral Researcher

    Ruhr-Universität Bochum

    Research and teaching activities in the field of molecular biology and genetics of lower procaryotes (fungi).

  • 4 years and 2 months, May 2014 - Jun 2018

    PhD Student

    Ruhr-Universität Bochum

    - 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.

  • 10 months, Aug 2015 - May 2016

    Laboratory Assistant

    Dr. August Oetker Nahrungsmittel KG

    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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