IMDRF 2023

2001-2006 Safety and Regulatory Engineer GE

New product introduction & Installed Base Introduction imaging software (Worldwide)

Management of regulatory compliance of new medical devices worldwide

2010-2011 Medical Device CE Marking Auditor (Free Lance)

2011 to January 2012: Regulatory Affairs Manager Philips Medical Systems

2015-2020 Head of Quality and Regulatory France

Management of team of 5 people.

Management of controls and inspections Competent authorities: French Competent Authorities (ANSM).Management of Post-Market Surveillance and corrective safety actions FSCA.

Leading of Regulatory Strategy.

Trade Association SNITEM active member of working groups:

EU MDR, Software prescription HAS certification, e-health, research, maintenance…

2021-2023 Head od Standard and Regulations

COCIR:

•RAC Vice-Chair

•Vigilance group Chair

•COCIR Representative at MDCG.

MedTech Europe:

•Philips Representative at RAC

•Vigilance & NB Working group

•EU Future regulatory Framework

SNITEM (French Trade Association):

•Interface Committee with ANSM (French Competent Authority)