Vivien Jourdannaud

Quality Assurance and Regulatory Affairs Director at Theraclion
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Contact Information
us****@****om
(386) 825-5501
Location
Greater Paris Metropolitan Region, FR
Languages
  • Français Native or bilingual proficiency
  • Anglais Full professional proficiency
  • Espagnol Elementary proficiency

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Experience

    • France
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Quality Assurance and Regulatory Affairs Director
      • Jan 2018 - Present

    • Quality Assurance and Regulatory Affairs Engineer
      • Oct 2015 - Jan 2018

    • United States
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Regulatory Affairs Specialist
      • Sep 2014 - Sep 2015

      • Products registration (class IIa) in Taiwan - Regulatory partner relationship management • Implementation of a new labeling process integrating the USFDA Unique Device Identifier requirements • Ensuring products compliance with quality and regulatory requirements • Active regulatory and standard watch • Working on the quality system of the firm • Products registration (class IIa) in Taiwan - Regulatory partner relationship management • Implementation of a new labeling process integrating the USFDA Unique Device Identifier requirements • Ensuring products compliance with quality and regulatory requirements • Active regulatory and standard watch • Working on the quality system of the firm

    • Hospitals and Health Care
    • 700 & Above Employee
    • Segmentation of volumetric liver images using dynamic contrast enhancement Dual-Energy CT scanner
      • Sep 2012 - Sep 2013

      • Development and evaluation of a segmentation program detecting the liver and its lesions from dual energy CT scan images • Assessment of the influence of the dose and the contrast agent on the segmentation quality • Trials on animals • Development and evaluation of a segmentation program detecting the liver and its lesions from dual energy CT scan images • Assessment of the influence of the dose and the contrast agent on the segmentation quality • Trials on animals

    • France
    • Biotechnology Research
    • 300 - 400 Employee
    • Implementation of test procedures to assess cross-frequency coupling phenomom on human subjects
      • May 2011 - Sep 2011

      • Scientific and technical monitoring of a new neurophysiological theory, the cross-frequency coupling • Biological signals recording with a magnetoencephalography • Development and assessment of a program quantifying the phenomenon • Establishment of a trial on subjects to highlight the phenomenon during a cognitive task • Scientific and technical monitoring of a new neurophysiological theory, the cross-frequency coupling • Biological signals recording with a magnetoencephalography • Development and assessment of a program quantifying the phenomenon • Establishment of a trial on subjects to highlight the phenomenon during a cognitive task

    • France
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Service Laboratoire Finishing
      • Jan 2010 - Feb 2010

      • Drill machine technical manual writting • Quality and manufacturing issues awareness • Drill machine technical manual writting • Quality and manufacturing issues awareness

Education

  • Ecole centrale de Lille
    Ingénieur diplômé de l'Ecole Centrale de Lille
    2009 - 2013
  • Université Paris Sud (Paris XI)
    Master 2 Professionnel en Alternance - CFA LEEM, "Qualité et Produits de Santé" option "Dispositifs Médicaux: Evaluation, enregistrement, vigilance"
    2014 - 2015
  • Universiteit Gent
    Double degree: Master of Biomedical Engineering, Biophysique, Biomedical
    2011 - 2013
  • Vrije Universiteit Brussel
    Double degree: Master of Biomedical Engineering, Biophysique, Biomedical
    2011 - 2013

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