Maria Cristina Exner
Quality Assurance/Regulatory Affairs Manager LATAM (QA/RA) at BioSud S.A.- Claim this Profile
Contact Information
us****@****om
(386) 825-5501
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Location
AR
Languages
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Portuguese Limited working proficiency
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English Professional working proficiency
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Experience
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BioSud S.A.
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France
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Construction
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Quality Assurance/Regulatory Affairs Manager LATAM (QA/RA)
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Mar 2009 - Present
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ITAES Instituto Técnico para la Acreditación de Establecimientos de Salud
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Argentina
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Hospitals and Health Care
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Expert
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Dec 2011 - Present
Healthcare Acreditation Healthcare Acreditation
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Freelance Work
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Business Consulting and Services
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1 - 100 Employee
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Consultant
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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
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G & E Consulting
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Human Resources Services
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Directivo
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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.
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Education
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Universidad Austral, Buenos Aires
Diplomatura, Health/Health Care Administration/Management -
Universidad de Buenos Aires
Especialización, Arquitectura -
Universidad Nacional del Litoral
Posgrado, Gestión de proyectos -
Universidad Nacional de Entre Ríos
Engineer's degree, Bioengineering and Biomedical Engineering -
IRAM - Filial Rosario
Auditor Líder, Gestión industrial/de ingeniería
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