Experience

BMDC / Brussels Medical Device Center

• Belgium
• Medical Equipment Manufacturing
• 1 - 100 Employee

• RA and Clinical Trial Manager

  • Nov 2020 - Present

  Regulatory strategy, writing and review of documentation and device conformity all along their life cycle (PRRC).Creation of documentation for clinical trial, follow-up and results analysis.

• QA/RA Manager

  • Aug 2019 - Nov 2020

  Maintenance of a quality management system ISO 13485 certified. Definition of regulatory inputs for medical devices in development phase up to the first clinical study.

• CTO

  • Jan 2019 - Jun 2020

  Projects management of medical device development from the idea to the safety study. Verification plan definition, test protocol writing. Search of sub-contracted manufacturer or test carrier. Redaction of documents for clinical study submission. Dialogue with competent authorities and clinical study follow-up.

• QA/RA Manager

  • Aug 2016 - Jan 2019

  Writing and implementation of a quality management system ISO 13485:2016 certified for medical device implantable or not up to class IIb.



Inserm U1148 - Laboratory for Vascular Translational Science

• PhD student, Biologic and medical Engineering

  • Nov 2011 - Oct 2014

  Design of a new stent coating for cardiovascular application European research program PRESTIGE - PREvention of Late Stent Thrombosis by an Interdisciplinary Global European effort Grant : the Groupe de Réflexion sur la Recherche Cardio-vasculaire, the Fédération Française de Cardiologie and the Société Française de Cardiologie ➢ Project management, supervision of trainee ➢ Production and optimisation of the synthesis of a copolymer ➢ In vitro tests : hemocompatibility, cell culture, bacteriology ➢ In vivo tests : rat and rabbit implantations ➢ Synthesis, bibliography, report and article writing



ITU Health, Safety and Environment - Université Paris 13

• Teacher

  • Sep 2012 - Jun 2014

  128h of tutorials classes and Practical work in physiology 128h of tutorials classes and Practical work in physiology

• Research Bioengineer

  • Feb 2011 - Jun 2011

  Research internship to improve the synthesis and assess the hemocompatibility of a copolymer of dextran and PBMA ➢ Optimization of the copolymer synthesis ➢ Assessment of CoCr hemocompatibility ➢ Protocols adaptation to other surfaces ➢ Synthesis and writing Research internship to improve the synthesis and assess the hemocompatibility of a copolymer of dextran and PBMA ➢ Optimization of the copolymer synthesis ➢ Assessment of CoCr hemocompatibility ➢ Protocols adaptation to other surfaces ➢ Synthesis and writing



CNRS - UMR 5558 Laboratoire de Biométrie et Biologie Évolutive

• Assistant Engineer

  • Jun 2010 - Aug 2010

  Research internship in the Biostatistics and Modelling for health and the environment, Evaluation and Modeling of therapeutic effects. Mathematical modeling of atheroma plaque formation and evolution Design of an in virtuo model ➢ Bibliography, synthesis and writing ➢ Hypothesis selection ➢ Stress modelling Research internship in the Biostatistics and Modelling for health and the environment, Evaluation and Modeling of therapeutic effects. Mathematical modeling of atheroma plaque formation and evolution Design of an in virtuo model ➢ Bibliography, synthesis and writing ➢ Hypothesis selection ➢ Stress modelling



AMJE Cluny

• France
• Industrial Machinery Manufacturing
• 1 - 100 Employee

• Design engineer

  • Feb 2010 - Jun 2010

  Engineer school project Design of a roaster for the firm Terra Kawa ➢ Project management ➢ Design and prototyping Engineer school project Design of a roaster for the firm Terra Kawa ➢ Project management ➢ Design and prototyping



CHU de Dijon - Cardio-Vascular Surgery department

• Observation intership

  • Nov 2008 - Nov 2008

  Familiarization with clinical environment Observation of different surgeries (orthopedics, cardiac, vascular, thoracic) Visualization of technical constraints of implantation Familiarization with clinical environment Observation of different surgeries (orthopedics, cardiac, vascular, thoracic) Visualization of technical constraints of implantation