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Sophie VAILLOT

BUC

En résumé

Leader of Center of Excellence for Postmarket - Europe, Africa, middle East, Russia & India

Regulatory Affairs Manager

Post market process leader : Support regulatory compliance and optimization of quality system procedures relating to post market reporting through the development, maintenance and improvement of documented processes.
Provide training, guidance and support to other regions for implementation of postmarket procedures

* Involved in EU working group as Cocir member (UDI, MEDG on vigilance, Trend reporting ..)

* involved in MDD revision as COCIR member

* SNITEM Working groups (French Trade Association for Medical Devices Manufacturers)

* Regulatory intelligence

Mes compétences :
Affaires réglementaires
MDD (medical device directive)
Analyse de risque
Qualité
Postmarket

Entreprises

  • GE HEALTHCARE - Pharmacien affaires reglementaires

    2009 - maintenant
  • Afssaps - Pharmacien affaires réglementaires - materiovigilance

    Saint-Denis 2001 - 2009 In charge of European and International affairs for postmarket

    - cooperation and exchange between European National Competent Authorities
    - European Medical Device Vigilance Group (EU commission, Bruxelles)
    - Meddev revision

    - Training of local medical device vigilance officer in French hospitals
    - Work on new Procedures for French medical device vigilance system
    - assessment of vigilance reports (cardiology, ophtalmology)

Formations

Réseau

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