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Camille ROY

En résumé

As a freelance in quality and regulatory affairs in the medical devices industry, I can provide my expertise for the following points :

-Implementation of a quality management system according to the EN ISO 13485 : 2016;

-Implementation of the technical file in order to obtain the CE marking;

-Realization of clinical evaluation reports through literature review;

-Realization of internal audits.

Being passionate about travel, I am totally mobile and adapt my way of life to my job.

Mes compétences :
CAPA
Marquage CE
Gestion du changement
Dossier technique
Evaluation clinique
Gestion des risques
Management de la qualité
Classe III
Audit interne
Classe II-a
SEMP
Orthopédie
Affaires réglementaires
ISO 60601-1
ISO 62366
ISO 14971
Imagerie médicale
ISO 13485
Dispositifs médicaux
Qualité

Entreprises

  • OSCADI - Spécialiste Qualité et affaires réglementaires

    2016 - 2017 ->Preparation of the technical file and the quality management system in order to obtain the CE marking for a class II-a medical device.

    ->Realization of the clinical evaluation report according to the Annex X of Directive 93/42/EC.

    ->Achievement of the risk management file according to the EN ISO 14971 and the usability engineering file according to the 63266 and the 60601-1-6.

    ->Participation in the redaction of the quality manual and procedures according to the EN ISO 13485.

  • Meddeva - Ingénieure Projet

    Chargé 2014 - 2016 ->Realization of clinical evaluation reports according to the Annex X of Directive 93/42/EC. (more than 15 files treated, involving more than 300 articles.)

    ->Contribution to the creation and maintenance of risks management files for orthopaedic and
    spinal implants.

    ->Contribution to the implementation of the quality management system according ISO 13485,
    including creation of procedures and work instructions, realisation of internal audits (BSI formation), implementation of corrective actions.

    ISO 13485 certification achieved in 2016

  • Meddeva - Stagiaire Ingénieure Projet

    Chargé 2013 - 2013 -Participation in literature reviews reports (data extraction)
    -Establishment of the fundamentals of a QMS (processes, procedures, risk analysis)
    -Assisting a company wishing to maintain regulatory compliance.

Formations

  • Université Bordeaux

    Bordeaux 2010 - 2013 Master’s program lasts 2 years, comprising a multidisciplinary coursework
    -Anatomy and biology
    -Chemistry and physico-chemical characterization
    -Mechanical properties of biomaterials
    -Good Manufacturing Practice (GMP)
    -Patent process and industry proceedures…

    Competences
    -Familiarization with
    the industries in the field of the biomaterial and medical devices
    French and European legislation
    medica

Réseau

Pas de contact professionnel

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