Laura NGUYEN VAN
Responsable des affaires réglementaires et assurance qualité at CG MEDICAL- Claim this Profile
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Français Native or bilingual proficiency
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Anglais - TOEIC 965/990 Professional working proficiency
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Espagnol Elementary proficiency
Topline Score
Bio
Experience
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CG MEDICAL
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France
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Responsable des affaires réglementaires et assurance qualité
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Jul 2019 - Present
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NEURO FRANCE Implants
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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 Manager
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May 2015 - Jul 2019
- Maintien du Système de Management de la Qualité selon l’ISO 13485:2016 (gestion documentaire, CAPA, non-conformités, …). - Maintien de la documentation technique pour le marquage CE des dispositifs médicaux de classe IIb (directive européenne 93/42/CEE). - Gestion des audits et relation avec l’Organisme Notifié. - Validation des procédés de nettoyage et de stérilisation par irradiation. - Participation aux dossiers d’enregistrement pour la France et l’export. - Veille réglementaire. Show less
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Arthesys S.A.
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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R&D Project Manager assistant
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Mar 2013 - Aug 2013
End-of-studies internship. Development of a new angioplasty catheter. Project Management and planning. End-of-studies internship. Development of a new angioplasty catheter. Project Management and planning.
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Creganna Medical
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Ireland
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Medical Equipment Manufacturing
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700 & Above Employee
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R&D Intern
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May 2012 - Aug 2012
Three-month internship as an assistant engineer. Correction and clarification of manufacturing processes. Creation of documentation to support manufacturing, quality and R&D. Three-month internship as an assistant engineer. Correction and clarification of manufacturing processes. Creation of documentation to support manufacturing, quality and R&D.
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CIC-BT CHU Besançon
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France
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Biomedical technician intern
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May 2011 - Aug 2011
Discovery of the hospital environment and the role of a biomedical technician. Discovery of the hospital environment and the role of a biomedical technician.
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Education
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Polytech Lyon
Engineer's degree, Biomedical engineering (GBM@Lyon) -
Lycée Victor Hugo
CPGE PCSI - PC -
Lycée Jules Haag - Besançon
Baccalauréat, Scientifique