María-José C.

Quality Assurance & Regulatory Affairs Manager / Responsable Técnico/PRRC (Medical Devices) at CeraRoot SL (MDR & MDSAP Certified)
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Contact Information
us****@****om
(386) 825-5501
Location
Greater Granollers Metropolitan Area, ES
Skills

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Experience

  • CeraRoot SL (MDR & MDSAP Certified)
    • Quality Assurance & Regulatory Affairs Manager / Responsable Técnico/PRRC (Medical Devices)
      • Jan 2020 - Present
  • Cex Internacional S.A.
    • Spain
    • Software Development
    • 1 - 100 Employee
    • Responsable Calidad/Técnico/Asuntos Regulatorios (QA/RA & Technical Manager Medical Devices)
      • Jan 1996 - Jan 2020

      Tareas como Responsable Técnico Productos Sanitarios. Mantener los Certificados de Marcado CE de Productos Sanitarios. Implantación del Sistema de Gestión de Calidad según EN ISO 13485. Tareas Responsable del Laboratorio de Control de Calidad. Trámites Licencia Fabricante. Auditorías. Interlocutora con Autoridades Sanitarias y Organismos Notificados. Comunicaciones de Comercialización. Trámites OBL/PLM para Marcado CE de clientes. Asesoramiento técnico a clientes. Trámites de Registro de Productos Sanitarios en otros países. Miembro Vocal de Comités Técnicos de Normalización para Sistemas de Gestión de Calidad y Métodos Contraceptivos. Interlocutora con Servicio Prevención Riesgos Laborales. Conocimientos de otras Normas: IVD MD Directive / IEC 62304 Medical Software. Implementation and maintenance of Quality Assurance System as per ISO 13485 and EC Certificates as per Directive 93/42/EEC concerning medical devices. Management of Quality Control Laboratory. Audits. Management of OBL/PLM for customers. Interlocutor with Health Authorities and Notified Bodies. Regulatory Affairs Management to register medical devices in other countries (i.e. EMEA Region, Russia, Mexico,...). Revision of Standards as Vocal Member of the Technical Standards Committee for Quality System ISO 13485 concerning medical devices and contraceptives methods (latex condoms). Familiarized with IVD MD Directive and IEC 62304 Medical software. Show less

Education

  • Universitat Autònoma de Barcelona
    Bachelor of Science - BS
    1988 - 1994
  • TecnoMed Ingenieros (Barcelona)
    Medical Devices Regulations-EN ISO 13485:2016
    2019 - 2019
  • A.E.F.I. (Barcelona)
    Nuevos Reglamentos Productos Sanitarios
    2016 -
  • Cambridge School
    Advanced English
  • GTF (Barcelona)
    2017 -
  • A.E.F.I. (Barcelona)
    FDA-Medical Device Quality System-21CFR820 (USA)
    2016 -
  • Tecno Med Ingenieros (Barcelona)
    Marcado CE Productos Sanitarios
    2015 -
  • A.E.F.I. (Barcelona)
    Quality Management System, CE Marking & Medical Devices Regulations
    2009 -
  • U.E.I. (Granollers)
    Prevención Riesgos Laborales (60 h)
    2009 -

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