Dr. Xi Chen

Angestellt, Senior Manager, Regional Lead, Clinical Evaluation Reporting, EMEA, Olympus Europa SE & Co. KG
Abschluss: Ph.D., Uni-Bremen
Hamburg, Germany

Fähigkeiten und Kenntnisse

MEDDEV 2.7/1 rev.4
Clinical Evaluation (EU/NMPA/CFDA)
Literature research
Plant Engineering
Microbiological lab techniques
Microarray
Plant-pathogen/beneficial microbe interaction
Plant defense/immune system
CRISPR-CAS9
RNA interference
Arbuscular mycorrhiza-rice infection
PCR
realtime PCR
RNA and DNA techniques
Protein expression
Cloning Library
Southern/Western Blot
Bacteria Transformation
Electroporation
Plant cell culture
Fluorescence microscopy
Gas chromatography
Electrophoresis
SDS-PAGE
Basics of MS

Werdegang

Berufserfahrung von Xi Chen

  • Current 1 year and 2 months, since Apr 2025

    Senior Manager, Regional Lead, Clinical Evaluation Reporting, EMEA

    Olympus Europa SE & Co. KG
  • 5 months, Nov 2024 - Mar 2025

    Team Lead Clinical Evaluation, EMEA

    Olympus Europa SE & Co. KG

  • 3 years and 1 month, Oct 2021 - Oct 2024

    Senior Clinical Affairs Manager

    Olympus Europa SE & Co. KG

  • 1 year and 9 months, Jan 2020 - Sep 2021

    Clinical Affairs Manager

    Olympus Europa SE & Co. KG

    Implementation of procedures for clinical evaluation, writer and reviewer of clinical evaluation reports, according to Medical Device Regulation (EU) 2017/745 (MDR), the guideline MEDDEV 2.7/1, 4th edition and current MDCG guidelines. Author and reviewer of clinical evaluation reports according to CFDA/NMPA Announcement 2015 No.14 (China). Supporting clinically relevant PMS and other technical documentation activities.

  • 1 year and 7 months, Jun 2018 - Dec 2019

    Clinical Affairs Consultant

    NSF Prosystem GmbH

    Implementation of procedures for clinical evaluation according to the Medical Device Directive 93/42/EEC (MDD), Medical Device Regulation (EU) 2017/745 (MDR) and the guideline MEDDEV 2.7/1, 4th edition. Author and reviewer of clinical evaluation reports for products of all risk classes according to MEDDEV 2.7/1, Medical Device Directive 93/42/EEC, and CFDA/NMPA Announcement 2015 No.14 (China). Business Development in the Chinese Market

  • 6 years and 4 months, Jul 2011 - Oct 2017

    Research Associate

    Universität Bremen

    It focused on discovering the candidate genes involved in resistance against an endophytic microbe.

  • 3 months, Sep 2016 - Nov 2016

    Internship Researcher

    Teikyo University

    Producing knockout mutants using CRISPR-Cas9 system; Japanese language learning.

Ausbildung von Xi Chen

  • 6 years and 4 months, Jul 2011 - Oct 2017

    Molekulare Biologie

    Uni-Bremen

    Dissertation Topic: “Approaches towards detection of candidate genes in Oryza sativa involved in endophytic colonization of Azoarcus sp. strain BH72” (1.3/ very good/magna cum laude)

  • 2 years and 9 months, Oct 2008 - Jun 2011

    Biochemistry and Molecular Biology

    Universität Bremen

    Thesis: “Detecting candidate genes in Oryza sativa involved in endophytic colonization with microarray“ (1.3/very good) Course Highlights: Advanced molecular biology in plant biology, Microbiology and cell biology, Protein analysis, Organic chemistry, Advanced practical training in microbiology.

  • 3 years, Oct 2005 - Sep 2008

    Biology

    Unilversität Bremen

    Bachelor thesis: “16s rDNA sequences analysis” (1.0/ very good). Course highlights: General biology education, with an emphasis on molecular biology.

  • 4 years, Sep 2001 - Aug 2005

    Human medicine

    Tongji-Universität

Sprachen

  • German

    C1 (Fließend)

  • English

    C1 (Fließend)

  • Chinese

    C2 (Verhandlungssicher / Muttersprachlich)

  • Japanese

    A1-A2 (Grundkenntnisse)

  • Polish

    A1-A2 (Grundkenntnisse)

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