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Mandine CASADO

Boulogne-Billancourt

Electionsmunicipales 2026

RETROUVEZ GRATUITEMENTRésultat municipales à Lyon
Résultat municipales dans le Rhône

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Entreprises

  • Medtronic - Regulatory Affairs Product Specialist, Regulatory Affairs Department

    Boulogne-Billancourt 2014 - maintenant • Generate technical files (class IIb and III) with the STeD format
    • Prepare 510(k), CE Marking file and other related regulatory filings to support registrations in USA, Europe, Australia and Canada
    • Support to worldwide registrations
    • Act as a Regulatory Affairs Core Team Member for several projects:
    - Definition, Documentation and Implementation of regulatory strategies for new technologies, new products
    - Provide regulatory support to design teams
    - Review of preclinical and clinical strategies to ensure the regulatory conformance
    - Review and Approval of the documentation proving the product conformity and supporting the regulatory submissions
    - Interface with R&D, Clinical, Quality, Manufacturing, Marketing, and Sales staff
    • Approval of Labeling
    • Regulatory monitoring and Information to the management and concerned departments

  • Johnson & Johnson - DePuySynthes - Regulatory Affairs Associate, Regulatory Affairs Department

    2012 - 2014 - Creation and Update of Technical File (DM: class I, IIa, IIb and III) for the CE marking
    - Knowledge of STeD format
    - Review and Approval of the documentation which demonstrates the compliance with the essential requirements
    - Follow-up of export requests to support the registrations in other countries
    - Implementation of French, European and American regulatory requirements
    - Regulatory monitoring

  • TBF Génie tissulaire - Trainee, Regulatory Affairs, Regulatory Affairs Department

    2011 - 2011 - Creation of the Module 3 of the CTD for the certification of an ATMP (Advanced Therapeutic Medicinal Product) y the EMA
    - Implementation of ICH Q9 and ISO 14971 in the risk management system
    - Creation of risk analysis
    - Regulatory monitoring

  • BioMérieux S.A., site de Grenoble - Trainee, Quality Assurance, QMS Department

    2009 - 2009 - Implementation of quality procedures following a manufacturing transfer

Formations

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