Kiran Singewar

Angestellt, Regulatory Affairs Specialist and Quality Assurance, LABiTec LAbor BioMedical Technologies GmbH
Ahrensburg, Germany

Skills

Regulatory Affairs
Quality Assurance
IVD Regulations
Medical device
Research
Genomics
Project Management
Team work
Communication skills
MS Office
Scientific Writing
Regulatory Compliance
Medical Devices
Life science
Quality Management
IVD
ISO 13485
Quality Testing
QMS
Support

Timeline

Professional experience for Kiran Singewar

  • Current 3 years and 9 months, since Feb 2023

    Regulatory Affairs Specialist and Quality Assurance

    LABiTec LAbor BioMedical Technologies GmbH

    Obtaining and maintaining national and international government approval for medical devices, and related materials. Inspecting products before, and during the manufacturing process to ensure that products align with the company's and legal standards. Ensuring that the products meet established quality standards and industry benchmarks. Working within the scope of the IVDR.

  • 1 year and 10 months, May 2021 - Feb 2023

    Postdoc Researcher/Wissenschaftler

    Thünen Institute

    Diagnosis Strategies through Genomics and DNA Barcoding. Treatment Strategies using RNA interference-mediated double-stranded RNA as biocontrol.

  • 4 months, Feb 2021 - May 2021

    Postdoctoral Researcher

    Christian-Albrecht University of Kiel

    Genomics, RNA transcriptome analysis, Expression analysis, Whole-genome sequence analysis, Scientific writing.

  • 2 years and 2 months, Apr 2019 - May 2021

    Quality Control Analyst (Part-Time)

    LABiTec LAbor BioMedical Technologies GmbH

    Apart from my main job as a researcher (Ph.D. Research), I invested some of my weekly hours in LABiTec. Here, I analyze the produced medical devices for the final quality control assurance before being distributed to respective customers worldwide. LABiTec produces automated and semi-automated coagulation as well as aggregation devices that are required in laboratory diagnostics worldwide.

  • 3 years and 8 months, Jul 2017 - Feb 2021

    Scientific Researcher (Ph.D. Research)

    Christian-Albrecht University of Kiel

    Molecular marker development and validation, Comparative Analysis, Whole-genome, Transcriptome, CLC Genomics Workbench.

  • 10 months, Jun 2016 - Mar 2017

    Student Research Assistant

    GEOMAR, Helmholtz Centre for Ocean Research Kiel, Germany

    Use of Gas Chromatography and Mass Spectrometry (GC/MS) Statistical data handling, Analysis, and Presentations

Languages

  • English

    C1 (Fluent)

  • German

    A1-A2 (Basic)

  • Hindi

    C2 (Expert / native speaker)

  • Marathi

    C2 (Expert / native speaker)

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