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Salim ZIANI

PARIS

En résumé

Currently, I work as a regulatory affairs specialist at Coloplast Manufacturing France.

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After a 4 year experience in cancer research, I worked for a year as a project manager in IHU Strasbourg an institute dedicated to innovation in Image-Guided Minimally Invasive Surgery. I managed a multidisciplinary team within a project of creating a start-up dedicated to development of medical devices.
Within this project I developed various skills related to Medical Device Innovation:
- Regulatory affairs (compliance with the requirements of the directive 93/42/EEC)
- Project management
- Team management
- Business plan and market study (especially, Gastro-Intestinal Interventional Flexible Endoscopy market).
- Start-up creation

Mes compétences :
Immunofluorescence
Veille scientifique
Culture cellulaire
Medical devices
93/42/CEE directive
Scientific writing
Project Management
Regulatory Affairs
Medical technologies
Dispositifs médicaux

Entreprises

  • Coloplast - Regulatory Affairs Specialist

    2016 - maintenant

  • DTF MEDICAL - Regulatory Affairs Specialist

    2016 - 2016 DTF Medical is a medium sized company developing medical devices in 3 fields: Aerosoltherapy, Breastfeeding and Wound care. During this mission, I was in charge of updating CE marking technical files, preparing a 510(k) for a class II device (in the field of breastfeeding), and I collaborated with R&D team in the development of a new Aerosoltherpy device (Risk management, Electrical safety, Usability engineering).

  • IHU Strasbourg (Institute of Image Guided minimally Invasive Surgery) - Project Manager

    2015 - 2015 - Project of creating a startup dedicated to development of medical devices for interventional flexible endoscopy.
    • Selection in the i-LAB 2015 startup creation contest – €45000 grant.
    • Incubation by Semia, Alsace startup incubator.
    • Management of an R&D team (1 engineer, 2 clinical fellows, 1 IP expert).
    • Regulatory affairs (USA and EU). Market and competitors. Business Plan.

    - Participation in organizing a course on MedTech innovation, B.E.S.T. Innovation course : Business, Engineering, and Surgical Technologies.

  • InSimo - Project Mnagement Trainee

    2014 - 2015 Market study on virtual reality simulators dedicated to surgical training. Survey with medical training centers in Europe.
    This work was a student project (pair work) within the master of Innovative Project Engineering.

  • IGBMC - Chercheur doctorant

    CHAMBRAY LES TOURS 2010 - 2014 - Research project management: Study of a DNA repair system (Nucleotide Excision Repair)
    - Scientific monitoring
    - Proposal and processing of innovative technical solutions
    - Analysis of results and definition of strategic orientations
    - Oral and written communication in English and French
    - Team work and intern students supervising

Formations

  • LNE-GMED

    Paris 2015 - 2015 Constitution of technical documentation for the establishment of compliance of medical devices with the requirements of Directives 93/42/EEC and 90/385/EEC (and their latest amendment, Directive 2007/47/EC).

  • Université De Strasbourg, Faculté Des Sciences Économiques Et De Gestion

    Strasbourg 2014 - 2015 Master 2

    Cette formation a pour but de doter les docteurs scientifiques et les ingénieurs de compétences managériales et d’aptitudes complémentaires requises par les entreprises et les organismes de transfert technologique dans les domaines de l’entreprise, du marché et de la gestion de projet.

  • IGBMC - Institut De Génétique Et De Biologie Moléculaire Et Cellulaire

    Illkirch 2010 - 2014 Doctorat

    Ecole doctorale Vie et Santé, Université de Strasbourg
    Sujet de thèse: Etude Fonctionnelle de la sous-unité TTDA du facteur de transcription/réparation TFIIH
    Directeur de Thèse: Dr. Frédéric COIN
    Institut de Génétique et de Biologie Moléculaire et Cellulaire, CNRS UMR 7104 - Inserm U 964
    1 rue Laurent Fries, 67404 Illkirch, France

  • Université De Strasbourg

    Strasbourg 2008 - 2010 Master 2

    Avec 6 mois de stage pratique en laboratoire de recherche (sujet: étude fonctionnelle de la sous-unité TTDA du facteur de transcription/réparation TFIIH)
    IGBMC (Institut de Génétique et de Biologie Moléculaire et Cellulaire, CNRS UMR 7104 - Inserm U 964)
    Illkirch, France.

  • Université Badji Mokhtar de Annaba

    Annaba 2003 - 2007 Pharmacien

    Diplôme algérien de pharmacien d'état.
    Cursus de 5 années, dont une année de stage interne en hôpital (Hôpital Pont Blanc, Annaba, Algérie):
    - 3 mois en laboratoire de microbiologie
    - 3 mois en laboratoire de biochimie clinique
    - 3 mois en pharmacie hospitalière
    - 3 mois en laboratoire d'hemobiologie.

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