Experience

Nexialist

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

• Founding Partner

  • Jan 2012 - 12 years

  La Ciotat - Regulatory Strategy and Compliance Expert - Over 10 years of experience in Medical Devices, In Vitro Diagnostics and Innovative Therapies Nexialist SARL: - Business consulting and advisory services to healthcare companies - New multidisciplinary and ethical approach for optimizing the development, the time to market and the post-market surveillance for medical innovations Personal skills: - General and support: > Business vision and overall… Show more - Regulatory Strategy and Compliance Expert - Over 10 years of experience in Medical Devices, In Vitro Diagnostics and Innovative Therapies Nexialist SARL: - Business consulting and advisory services to healthcare companies - New multidisciplinary and ethical approach for optimizing the development, the time to market and the post-market surveillance for medical innovations Personal skills: - General and support: > Business vision and overall strategy > Due Diligence > Mediation and coaching > Subcontractors control > Training - Quality: > ISO 9001, ISO 13485, 21 CFR 820 > GMP, GLP, GCP > Certified quality auditor ISO 9001, ISO 13485 > Risk analysis and management - Regulatory Affairs: > Marketing authorization > MD regulation, innovative therapies, IVDs > Medical device vigilance > International conformity > Regulatory Intelligence - Market: > Post-market surveillance > Clinical trials > CNIL

• Founder - Freelance Consultant

  • Apr 2006 - Dec 2011

  Carnoux en Provence - Business consulting and advisory services to healthcare companies - New multidisciplinary and ethical approach for optimizing the development, the time to market and the post-market surveillance for medical innovations Support and assistance to healthcare companies: - Regulatory strategy for medical products approval path and filing (Americas, Europe, Asia); - Support to R&D teams in the early phase of product design to ensure faster compliant development; - International… Show more - Business consulting and advisory services to healthcare companies - New multidisciplinary and ethical approach for optimizing the development, the time to market and the post-market surveillance for medical innovations Support and assistance to healthcare companies: - Regulatory strategy for medical products approval path and filing (Americas, Europe, Asia); - Support to R&D teams in the early phase of product design to ensure faster compliant development; - International submissions: design dossier and technical file development, lead of CE marking, 510(k) and HDE projects; - Scientific, regulatory and compliance due diligence; - Building of quality management systems in compliance with ISO 13485, 21CFRxxx, CMDCAS, GLP, etc.; - Lead of ISO certification efforts; - Interface with Regulatory Bodies: FDA, Notified Bodies, competent authorities; - Creation and implementation of clinical strategies for product development, IRB submissions, protocol and informed consent development; - Facilitation of ISO 14971 risk management assessments; - 2nd party audits according to ISO 13485 and 21CFRpart820.



In Visio

• United States
• Architecture and Planning

• Founder

  • Dec 2006 - 2009

  Coaching of Teams, Executives and C-level Managers.



IPSOGEN

• Hungary
• Travel Arrangements

• Director Quality and Regulatory Affairs

  • Jan 2002 - Dec 2005

  Marseille Area, France In-Vitro Diagnosis Medical Device: Design and Manufacturing of Molecular IVDs for Cancers screening. - Set-up of an ISO 13485 Quality Management System; - Europe: CE marking for a DNA chip for diagnosis (MLL ChIP) and for several molecular diagnostics kits; - USA: Humanitarian device exemption for MLL ChIP.



Behavioural Neurosciences Laboratory, Cardiff University

• Reseach Fellow

  • 1999 - Jan 2001

  Cardiff, United Kingdom



Laboratoire Asepsys

• France

• R&D Project Manager

  • 1998 - 1999

  La Teste-de-Buch, France Medical device: Design and manufacturing of hygiene medical device



Psychology Department, York University

• Canada
• 1 - 100 Employee

• Research Fellow

  • 1996 - 1997

  York, United Kingdom