Regulatory Affairs

hace 2 semanas


Mexico City Connectingology A tiempo completo

Buscamos un Regulatory Affairs con experiencia en dispositivos médicos y conocimiento en regulaciones ISO y normativas específicas de la región LATAM. Este rol es clave en la gestión y mejora del Sistema de Gestión de Calidad (QMS) para la región, cumpliendo con requisitos regulatorios de ANVISA y otras normativas de buenas prácticas.


Responsabilidades
  • Implementar y liderar el QMS, asegurando el cumplimiento con ISO 13485 y normativas locales (México-Brasil)
  • Gestionar y mejorar continuamente procesos de calidad, con énfasis en la mejora continua y cumplimiento normativo.
  • Capacitar al personal en procesos de cumplimiento, gestionar registros de capacitación y asegurar la calidad en servicios de atención al cliente y soporte de campo.
  • Realizar investigaciones en procesos CAPA y colaborar en actividades de Vigilancia Postmercado.


Requisitos:
Requisitos
  • Licenciatura terminada
  • Experiencia comprobable en gestión de calidad y cumplimiento de normativas ISO 13485, con conocimientos avanzados en calidad para dispositivos médicos.
  • Capacidad para liderar proyectos de mejora continua y gestionar proveedores.
  • INGLÉS AVANZADO (Indispensable)
  • Portugues avanzado (deseable)


Ubicación: México (Disponibilidad para viajar LATAM)




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