Experience

HRA Pharma

• France
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Regulatory Affairs Manager - Medical Devices

  • Jun 2019 - Present



Septodont

• France
• Medical Equipment Manufacturing
• 700 & Above Employee

• Regulatory affairs officer - Medical device CE marking

  • Mar 2015 - May 2019

  Regulatory referent for new devices projects / Establishment of regulatory strategies Europe / USARegulatory referent within an innovation circle/project catalystEdition and submission of combined devices files, renewals and variations of class III devicesPreparation and update of technical documentation (class I to III devices)Implementation of a regulatory action plan to maintain the Septodont CE certificationCreation and implementation of a reg template in connection with 2017/745/EC requirementsTechnical and regulatory support to export department for international devices submissionsTeam referent for regulatory and normative watch (Medical device / Cosmetic / Biocide)Interaction with notified bodies and authorities - Audit/Inspection managementLead on internal audits and regulatory trainings within US and Brazilian Septodont subsidiariesValidation of medical devices packagingManagement of trainees / junior officers



LEMER PAX

• Quality & Regulatory affairs engineer

  • Oct 2014 - Mar 2015

  Upgrade of technical files with EU reg requirements for the 1st GMED audit of the company Management of quality assurance system (ISO 9001 / ISO13485)Creation and update of LEMER PAX technical files (IIb / Im / Is class devices)Post-market data analysis (MD vigilance system)Implementation of bibliographic clinical evaluation and risk managementLabelling & manual compliance with applicable standards Upgrade of technical files with EU reg requirements for the 1st GMED audit of the company Management of quality assurance system (ISO 9001 / ISO13485)Creation and update of LEMER PAX technical files (IIb / Im / Is class devices)Post-market data analysis (MD vigilance system)Implementation of bibliographic clinical evaluation and risk managementLabelling & manual compliance with applicable standards



Sorin Group

• Italy
• Medical Equipment Manufacturing
• 300 - 400 Employee

• Regulatory affairs Intern

  • Apr 2014 - Sep 2014

  Creation of a CE technical file compliant with others regulatory requirements such as Canada, Australia and STED, while conforming to French and European requirementsCreation and update of European regulatory files for cardiac medical devicesRegulatory submissions of implantable medical devices in Latin America Health data Privacy and Security in Europe and RussiaMonitoring of internal audits – Procedures development and update Creation of a CE technical file compliant with others regulatory requirements such as Canada, Australia and STED, while conforming to French and European requirementsCreation and update of European regulatory files for cardiac medical devicesRegulatory submissions of implantable medical devices in Latin America Health data Privacy and Security in Europe and RussiaMonitoring of internal audits – Procedures development and update



CNRS

• France
• Research Services
• 700 & Above Employee

• Research assistant - Intern

  • Apr 2013 - Jun 2013

  Characterization of molecular players involved in transintestinal cholesterol excretion Characterization of molecular players involved in transintestinal cholesterol excretion



INSERM

• France
• Research Services
• 700 & Above Employee

• Research assistant - Intern

  • Oct 2011 - Mar 2012

  Metabolic and epigenetic changes in colon cells induced by energy sources Metabolic and epigenetic changes in colon cells induced by energy sources