MARCY-L'ETOILE2014 - 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…
Guyancourt2002 - 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
