Experience

nexialist

• France
• Business Consulting and Services
• 1 - 100 Employee

• Regulatory Compliance Specialist

  • Sep 2022 - Present



GMED

• France
• Medical Equipment Manufacturing
• 100 - 200 Employee

• Product reviewer

  • Mar 2019 - Sep 2022



Pierre Fabre Group

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Cosmetic Regulatory Affairs Manager

  • Feb 2016 - Mar 2019

  - Team management (4 persons) - EU cosmetic files assessment (PIF) (1223/2009 regulation) - Cosmetic claim assessment (655/2013 regulation) - Cosmetic ingredient assessment - Implementation of international registration files - Work on umbrella brand strategy - Member of European working groups (Cosmetics Europe) - Team management (4 persons) - EU cosmetic files assessment (PIF) (1223/2009 regulation) - Cosmetic claim assessment (655/2013 regulation) - Cosmetic ingredient assessment - Implementation of international registration files - Work on umbrella brand strategy - Member of European working groups (Cosmetics Europe)



Pierre Fabre Group

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Medical Device Regulatory Affairs Manager

  • Jan 2012 - Feb 2015

  - Pilot of Risk Management process (according to ISO 13485) - Labelling / Promotional material assessment - Assessment of sterilisation validation report - Implementation and assessment of EC mark and international registration files (class I, II-a, III) - Pilot of Regulatory Affairs Process (according to ISO 13485) - Implementation of analysis on borderline issues (substance-based devices) - Implementation of bibliographic clinical assessment report - Redaction of internal regulatory watch newsletter Show less



PIERRE FABRE DERMO-COSMETIQUE

• France
• Personal Care Product Manufacturing
• 200 - 300 Employee

• Regulatory Affairs project manager

  • Nov 2006 - Dec 2011



THT BIO-SCIENCE

• France
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Medical Device Regulatory Affairs Manager

  • 2002 - 2005

  Under annex II, Directive 93/42/CEE, Implementation of: - EC mark files (implantable, class III) - Clinical evaluation report - Biocompatibility report - Sterilisation report validation (gamma and EtO sterilisation) - Reimbursment files - Risk Management files Labelling assessment Under annex II, Directive 93/42/CEE, Implementation of: - EC mark files (implantable, class III) - Clinical evaluation report - Biocompatibility report - Sterilisation report validation (gamma and EtO sterilisation) - Reimbursment files - Risk Management files Labelling assessment



Meditest internationnal

• Région de Rennes, France

• Medical Device Regulatory Affairs Consultant

  • 2001 - 2002

  Consultant for Medical Device companies : - Implementation of EC technical files: clinical evaluation report, biocompatibility report, sterilisation validation report, risk management report, labelling assessment - Quality system implementation and follow-up (ISO 13485) - Implementation of reimbursment files Consultant for Medical Device companies : - Implementation of EC technical files: clinical evaluation report, biocompatibility report, sterilisation validation report, risk management report, labelling assessment - Quality system implementation and follow-up (ISO 13485) - Implementation of reimbursment files



Materialise

• Belgium
• Software Development
• 700 & Above Employee

• Regulatory / Quality manager

  • Jul 2000 - Jul 2001

  - Quality System Management (EN 13485) - Regulatory Affairs Management (implantable class II-b and III devices, custom-made devices) - Participation to European Research program (4th PCRD) - Quality System Management (EN 13485) - Regulatory Affairs Management (implantable class II-b and III devices, custom-made devices) - Participation to European Research program (4th PCRD)