Sophie DUCONGER

En résumé

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

• Bordeaux Ecole De Management

  Bordeaux 2001 - 2002 Quality Management, option Santé
  
  P13

Réseau

• Bruno RAULT

• Denis BOUILLET

• Hervé LE BERRE

• Hervé REIGNAC

• Marie-Andrée LE BOURDON

• Pierre HÉLIAS

• Rudy DELAMARRE

• Sébastien STOITZNER

• Virginie ROSSI