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Sophie DUCONGER

MARCY-L'ETOILE

En résumé

Quality - Regulatory Affairs & Risks Transition Manager

Mes compétences :
Gestion de projet
Qualité
Affaires réglementaires

Entreprises

  • BioMérieux - Regulatory Compliance Transition Spécialist

    MARCY-L'ETOILE 2014 - 2015 - Vigilance & Field Actions processes within the EMEA scope (Incidents, FA board, FCA, FSCA, CAPA follow-up)
    - Regulatory compliance (European, FDA and French regulations)

  • Smith & Nephew Orthopaedics France - Quality-Regulatory Affairs & Risks manager

    2008 - 2013 - Active contribution to the operational & social merger between S&N and Plus
    Orthopedics France in an international environment- Services Rationalization &
    Optimization (supply chain, complaint management, best practices between both
    companies…)
    - Complaint Handling Management policies in interface with the French & international
    authorities & the medical devices manufacturers (EU, US)- vigilance incidents, recalls,
    FAN…
    - Implementation & Maintain of both Quality certifications ISO13485-2003 and ISO
    9001-2008
    - Establishment of a Global Risk Management Program: professional wake-up,
    insurances, vigilance, experts & lawyers (patient claims follow up)
    - Settlement & piloting of Regulatory wake-up, integration of European & French
    compliance & regulations: DMI Up-classification class III, French Sunshine Act,
    Medical Devices Advertising French Decree…

  • SOCOTEC Consulting - Consultant Senior Change Management- Quality & Risk management

    Guyancourt 2002 - 2008 - Assistance & implementation of Change management programs in different
    sectors like Industry, Healthcare & Services.
    - Projects of Performance optimization & improvement: Project Management, ISO
    9001, ISO13485 certifications - Global Risk Management - Reorganization of services -
    Optimization of performances - Performance indicators settlement (BSC)-Sales &
    Marketing action plans…
    - Creation and animation of training courses: Quality Management - Risk
    management - Project Management
    - Strategic Diagnosis & assistance to the implementation of new company strategy
    - Implementation of organizational audits: risks & quality certifications (ISO
    9001,ISO13485)

  • CH de Pau et Clinique Chirurgicale Larrieu - Chef de projet Qualité et gestion de risques

    2001 - 2002 - Definition & implementation of a Global Quality Improvement Plan & Patient Care
    Security
    - Lead of transversal steps of progress: Accreditation - Vigilances coordination -
    Global Risk Management
    - Capitalization of accreditation results through a Corrective Action Plan – Audits

Formations

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