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Yann BARLET

Marnes La Coquette

En résumé

Mes compétences :
Biocompatibilité
ISO 13485
MALADIES RARES et ORPHELINES
Quality assurance
ISO 10993
Validation
Change control
CAPA
Data Quality
Management de projets internationaux
21 CFR part 11
GXP
Biotechnologies
Computer system validation
SOP
Tests
ECRF
Dispositifs médicaux
Registre Patients
Cross functional management
Système qualité
Requirements analysis and specifications

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

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