Vivien Jourdannaud
Quality Assurance and Regulatory Affairs Director at Theraclion- Claim this Profile
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Français Native or bilingual proficiency
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Anglais Full professional proficiency
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Espagnol Elementary proficiency
Topline Score
Bio
Experience
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Theraclion
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France
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Medical Equipment Manufacturing
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1 - 100 Employee
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Quality Assurance and Regulatory Affairs Director
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Jan 2018 - Present
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Quality Assurance and Regulatory Affairs Engineer
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Oct 2015 - Jan 2018
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Mauna Kea Technologies
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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Regulatory Affairs Specialist
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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
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UZ Brussel
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Hospitals and Health Care
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700 & Above Employee
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Segmentation of volumetric liver images using dynamic contrast enhancement Dual-Energy CT scanner
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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
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Institut du Cerveau – Paris Brain Institute
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France
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Biotechnology Research
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300 - 400 Employee
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Implementation of test procedures to assess cross-frequency coupling phenomom on human subjects
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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
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Essilor Group
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France
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Medical Equipment Manufacturing
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700 & Above Employee
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Service Laboratoire Finishing
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Jan 2010 - Feb 2010
• Drill machine technical manual writting • Quality and manufacturing issues awareness • Drill machine technical manual writting • Quality and manufacturing issues awareness
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Education
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Ecole centrale de Lille
Ingénieur diplômé de l'Ecole Centrale de Lille -
Université Paris Sud (Paris XI)
Master 2 Professionnel en Alternance - CFA LEEM, "Qualité et Produits de Santé" option "Dispositifs Médicaux: Evaluation, enregistrement, vigilance" -
Universiteit Gent
Double degree: Master of Biomedical Engineering, Biophysique, Biomedical -
Vrije Universiteit Brussel
Double degree: Master of Biomedical Engineering, Biophysique, Biomedical