BUC
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
