Maria Cristina Exner

Quality Assurance/Regulatory Affairs Manager LATAM (QA/RA) at BioSud S.A.
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Contact Information
Location
AR
Languages
  • Portuguese Limited working proficiency
  • English Professional working proficiency

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Experience

    • France
    • Construction
    • Quality Assurance/Regulatory Affairs Manager LATAM (QA/RA)
      • Mar 2009 - Present
    • Expert
      • Dec 2011 - Present

      Healthcare Acreditation Healthcare Acreditation

    • Business Consulting and Services
    • 1 - 100 Employee
    • Consultant
      • Jan 2006 - Present

      Good Manufacturing Practice for Medicinal Devices ISO 13485 Medical Devices - Quality Management Systems - Requirements for Regulatory Objectives ISO 14971 - Medical Devices Risk Management CE Mark FDA Design of Clean Areas Good Manufacturing Practice for Medicinal Devices ISO 13485 Medical Devices - Quality Management Systems - Requirements for Regulatory Objectives ISO 14971 - Medical Devices Risk Management CE Mark FDA Design of Clean Areas

    • Human Resources Services
    • Directivo
      • Nov 2009 - Aug 2018

      Search & Selection of Human Resources Specialized to the Medical Device Sector. Search & Selection of Human Resources Specialized to the Medical Device Sector.

Education

  • Universidad Austral, Buenos Aires
    Diplomatura, Health/Health Care Administration/Management
    2020 - 2021
  • Universidad de Buenos Aires
    Especialización, Arquitectura
    2017 - 2017
  • Universidad Nacional del Litoral
    Posgrado, Gestión de proyectos
    2009 - 2009
  • Universidad Nacional de Entre Ríos
    Engineer's degree, Bioengineering and Biomedical Engineering
    2002 - 2009
  • IRAM - Filial Rosario
    Auditor Líder, Gestión industrial/de ingeniería
    2006 - 2006

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