Yann BARLET

En résumé

Entreprises

• BIO-RAD - Technical & Regulatory Coordinator

  Marnes La Coquette 2014 - maintenant * Technical folders :
  - In collaboration with RA/QA, define the constitution of the instruments’ technical folders, targeting the CE marking, the US export (including 510k) and ROW.
  - Establishment of folders, in respect of plannings, internal processes, regulatory and standards requirements.
  - Definition and follow-up of corrective actions needed according to regulatory requirements.
  - Check and update folders regarding instruments’ evolutions.
  
  * Regulatory monitoring:
  - Monitoring of regulations and standards' evolutions (technical, safety, environment,…) related to instruments developed by R&D division of Bio-Rad.
  - Support and advise the various departments and project teams, impacted by current regulations (Dir.98/79/EC, FDA, ...).

• PC PAL - QA Engineer / Project Manager

  2007 - 2014  Improvements of quality processes
  - SOPs update and review
  - Audits / CA-PA
  - Management of tests & documentations / Justification of validations criteria
  - Helpdesk processes: traceability; forms creation; training of sponsors
  
   International projects management : Switzerland – USA - Sweden – France
  - Customized projects definitions and collect of needs for each customers: Pharmaceutical industries / Patients’ Associations & physicians
  - Translation of the needs from functional design specifications into technical design specification
  - Customers relationship
  - Cross-functional coordination: customers / development team (7p) / documentation team (4p)
  - Support/Helpdesk for users: sponsors, physicians & CROs
  - Simultaneous management of multi projects
  - Tests; Qualifications; Validations; Releases
  

• Sorin - Qualification Engineer

  Paris 2006 - 2007  Biocompatibility of used materials in active implantable medical devices (pacemakers, defibrillators and leads)
  - Synthesis of biomaterials used in process of conception V.S regulatory requirements in terms of biocompatibility
  - Statuses on the current « trouble spots » and proposals.
  - Awareness and creation of a biocompatibility guide based on regulatory requirements (FDA, EMA, MHLW) in order to improve costs and timeframe
  
   Overhaul of the qualification documentation system for the implantable pacemakers, defibrillators and leads.
  - Collect of needs (Regulatories, QA and projects managers)
  - Standards analysis
  - Initiation of functional analysis
  - Review of protocols & assays’ relevance, in order to create shared documentation for Montrouge (France) / Saluggia (Italy) sites

Formations

• Université Paris 11 Paris Sud (Chatenay Malabry)

  Chatenay Malabry 2004 - 2006 Master from conception to quality of drugs and other health products

• Université Paris 11 Paris Sud

  Orsay 2003 - 2004 Licence Chimie (spé Organique)

• Université Paris 11 Paris Sud

  Orsay 2001 - 2003 DEUG SM

Réseau

• Baptiste LABORIE

• Frédéric HEBERT

• Guillaume DURBEC

• Laure-Allison VERBOUX

• Manuel BABOLAT

• Matthieu BELLYNCK

• Maud JACUBERT

• Maxime LESPAGNOL

• Nicolas KARADJIAN

• Stéphane DOUCET