Laura NGUYEN VAN

Responsable des affaires réglementaires et assurance qualité at CG MEDICAL
  • Claim this Profile
Contact Information
us****@****om
(386) 825-5501
Location
Greater Lyon Area, FR
Languages
  • Français Native or bilingual proficiency
  • Anglais - TOEIC 965/990 Professional working proficiency
  • Espagnol Elementary proficiency

Topline Score

Topline score feature will be out soon.

Bio

Generated by
Topline AI

You need to have a working account to view this content.
You need to have a working account to view this content.

Experience

    • France
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Responsable des affaires réglementaires et assurance qualité
      • Jul 2019 - Present

    • France
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Quality Assurance Manager
      • 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

    • United States
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • R&D Project Manager assistant
      • 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.

    • Ireland
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • R&D Intern
      • 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.

    • France
    • Pharmaceutical Manufacturing
    • 100 - 200 Employee
    • Biomedical technician intern
      • 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.

Education

  • Polytech Lyon
    Engineer's degree, Biomedical engineering (GBM@Lyon)
    2010 - 2013
  • Lycée Victor Hugo
    CPGE PCSI - PC
    2008 - 2010
  • Lycée Jules Haag - Besançon
    Baccalauréat, Scientifique
    2005 - 2008

Community

You need to have a working account to view this content. Click here to join now