Regulatory Affairs
hace 2 semanas
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.
- 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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