Sophie Marcoux
Director, International Regulatory Affairs @Argon Medical Devices, Inc.
Gainesville, FL, US
EMAILS
MOBILE NUMBERS
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WORK HISTORY
Sep 2023 — Present
Director, International Regulatory Affairs @Argon Medical Devices, Inc.
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EDUCATION
2000 — 2000
University of Florida
Food Engineering
1997 — 2001
Université Laval
Bachelor of Engineering (BEng), Food Engineering
1995 — 1997
Cégep de Drummondville
DEC, Sciences
SKILLS
Fda GmpR&DProject PlanningMarket DevelopmentFmeaProduct DevelopmentU.s. Food and Drug Administration (Fda)Regulatory RequirementsBiomaterialsIso 14971Change ControlBiomedical EngineeringIsoSopFdaRegulatory AffairsIso 10993Ce MarkingResearch and Development (R&D)Capital Equipment21 CfrDesign for ManufacturingQuality AssuranceVerification and Validation (V&V)Design ControlIso StandardsQuality ManagementQuality SystemV&VCommercializationVascularMedical DevicesCapaDesign of ExperimentsIso 13485GmpDisposablesValidationInterventional RadiologyProduct Design
ABOUT SOPHIE MARCOUX
Director, International Regulatory Affairs at Argon Medical
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