Dr. Daria Radchenko

Angestellt, Lead Auditor (non-active medical devices), TÜV SÜD Product Service GmbH

Abschluss: Dr. rer. nat., Ruhr-Universität Bochum

Bern, Schweiz

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

  • Bis heute 1 Jahr und 5 Monate, seit 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 Jahr und 6 Monate, Juli 2021 - Dez. 2022

    Auditor (non-active medical devices)

    TÜV SÜD Product Service GmbH
  • 1 Jahr, Juli 2020 - Juni 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 Jahr und 1 Monat, Juni 2019 - Juni 2020

    Junior Regulatory Affairs Manager

    bitop AG

  • 8 Monate, Aug. 2018 - März 2019

    Postdoctoral Researcher

    Ruhr-Universität Bochum

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

  • 4 Jahre und 2 Monate, Mai 2014 - Juni 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 Monate, Aug. 2015 - Mai 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 Jahre und 2 Monate, Mai 2014 - Juni 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 Jahre und 9 Monate, Sep. 2007 - Mai 2012

    Biology

    Donetsk National University

Sprachen

  • Ukrainian

    Muttersprache

  • Russisch

    Muttersprache

  • Spanisch

    Grundlagen

  • Englisch

    Fließend

  • Deutsch

    Fließend

Interessen

Yoga
Graphic Art

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