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Philippe SCUILLER

MEYZIEU

En résumé

Mes compétences :
Audit and Quality Assurance (US & EU) for the medi
Regulatory Affairs specialist for medical devices
Approvals of medical devices and combination produ
Business management
Functional management
Product design
Urology
Anaesthesia
Blood sugar management
Surgery

Entreprises

  • Medical Devices & Combination Products - REGULATORY COMPLIANCE OFFICER & SANOFI Medical Devices /Francfort Design and Development

    2011 - maintenant Supervision : 3 persons (1 RA specialist, 2 QA specialists)

    * Member of working groups for future developments, international regulatory strategy definitions ;
    * Organization of meetings with Authorities (TÜV, FDA) ;
    * Trainings of Personnel about international regulations (21 QSR 820, ISO 13485, 14971, 62366, ...) ;
    * Results: CE marking & 510(k) clearance for 2 IVDs : blood glucose meters, preparation of several files for market approvals (US, EU, ROW): combination products and class II (US) and IIb products (EU) ;

  • Sanofi - Affaires réglementaires

    Paris 2011 - maintenant

  • TÜV Rheinland France - LEAD AUDITOR

    Courbevoie 2008 - 2010 Notified Body - Products and Quality Management Systems Certifications

    * Auditor ``IRCA'' (International Register of Certified Auditors), auditor for Health Canada (CMDCAS) ;
    * Preparation / presentations of training programs: FDA Inspections, European Directive amendment ;

  • CardinalHealth - Alaris Products - PRODUCT MANAGER France

    2003 - 2008 Manufacturer of Medical Devices dedicated for IV infusions of medications

    * Promotion of a software: over 15 hospital departments have chosen our product within 2 years ;
    * Development coordinator for a new concept of syringe pump dedicated for intravenous anaesthesia ;
    * Submissions and follow-up of clinical investigations to validate specific or new clinical applications ;
    * Close cooperation with the sales force and promotion of the products to hospital directors and department heads. Regular meetings with the international Product Team ;

  • Edap Technomed - QUALITY & REGULATORY AFFAIRS DIRECTOR

    1991 - 2003 Manufacturer of MD intended for minimal invasive surgery : Domain : Urology
    Supervision : 8 persons (Quality Engineers, RA and MD certification specialists)

  • Vial Medical (Division de Becton Dickinson) - Responsable R&D et Chef de Produit

    1984 - 1991 * Certification of products, launch of several medical devices intended for use in hospitals and home care for parenteral infusion of drugs and deliveries of enteral feeding

  • Fichet - Sales representative and manager of the subsidiary of the company located in Grenoble

    1976 - 1983 Manufacturer of safes, safety locks, alarm systems, and building surveillance platforms
    Supervision : 1 assistant, 3 specialized technicians

Formations

  • School Of Commerce Of Paris

    Paris 1970 - 1972 Bachelor of Commerce

    * Certified Engineer (Domain: Organization), certified auditor (IRCA), and auditor for Health Canada ;

Réseau

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