Maike Andersson

ist zurzeit gebucht. 

Freiberuflich, Medical Writer/Clinical Affairs, Andersson Medical Writing
Hamburg, Germany

Fähigkeiten und Kenntnisse

Clinical Evaluation Reports (MDD/MDR)
Medical Devices
13 Jahre Fachexpertise
Medizinprodukte
Stoffliche Medizinprodukte
Substance-based medical devices
Klinische Bewerung
Biocompatibility Evaluation Reports
Regulatory Affairs
Medical Writing
ISO 10993-2018
Literature Researches
Pharmakovigilanz
Medical Device Regulation
Complaint management
Kreative Lösungen

Werdegang

Berufserfahrung von Maike Andersson

  • Current 2 years and 1 month, since May 2024

    Medical Writer/Clinical Affairs

    Andersson Medical Writing

  • Current 4 years and 8 months, since Oct 2021

    Regulatory and Clinical Affairs Managerin

    qtec services GmbH

  • 6 months, Mar 2021 - Aug 2021

    Clinical Affairs Managerin

    Johner Institut GmbH
  • 1 year, Mar 2020 - Feb 2021

    Consultant Medical Devices/Clinical Affaires

    Diapharm GmbH & Co. KG

    Clinical Evaluation Reports according to MDD/MDR for all risks classes, specialist for substance-based medical devices, Biocompatibility Evaluation Reports according to ISO 10993-2018, Medical Writing, Literature Researches, Complaint Management, Consulting

  • 12 years, Nov 2007 - Oct 2019

    Lead Medical Device/Senior Pharmacovigilance Managerin

    Dr. Ebeling & Assoc. GmbH

    Clinical Evaluation Reports according to MEDDEV 2.7/1 Rev. 4, CTD Modules 2.4 and 2.5, PSURs, Signal Detection, Biocompatibility Evaluation Reports according to ISO 10993-2018, Medical Writing, Literature Researches,

  • 5 months, Mar 2007 - Jul 2007

    Research Assistant

    Department Biologie der Universität Hamburg

    Development of an eMedia concept and media development plan for the Department of Biology at the University of Hamburg

  • 2 years, Feb 2005 - Jan 2007

    Research Assistant

    Biozentrum Klein Flottbek der Universität Hamburg

    Development of a computer-based, interactive identification key for the determination of botanical seeds and fruits

  • 2 years, Mar 2003 - Feb 2005

    Research Assistant

    Fachbereich Biologie der Universität Hamburg

    Coordinator of a pilot project on the development of an eLearning-based master study program of applied Botany at the University of Hamburg

Ausbildung von Maike Andersson

  • Current 23 years and 5 months, since 2003

    Biologie

    Universität Hamburg

    Main focus: Applied botany and secondary plant metabolites Thesis: Andersson, M. et al. “Structure and function of the seed coat of Theobroma cacao L. and its possible impact on flavour precursor development during fermentation.” Journal of applied botany and food quality 80 (2006): 48-62.

Sprachen

  • German

    C2 (Verhandlungssicher / Muttersprachlich)

  • English

    C1 (Fließend)

  • Spanish

    C1 (Fließend)

  • French

    A1-A2 (Grundkenntnisse)

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