Regulatory Affairs Specialist III
Encontrado en: Talent MX C2 - hace 3 semanas
Objetivo:
Garantiza el cumplimiento regulatorio de los dispositivos médicos, productos de ciencia-investigación y de salud animal comercializados en México en un nivel táctico.
Responsabilidades:
Productos de Diagnóstico In Vitro
Planificación y ejecución de nuevos registros, modificaciones y renovaciones de dispositivos médicos. Solicitud de documentos técnicos y legales a sitios de fabricación. Comunicación y coordinación con distribuidores titulares de registros sanitarios. Coordinación y supervisión de consultores y gestores que apoyan con el armado y sometimiento de expedientes ante COFEPRIS bajo titularidad de la compañía. Participación en reuniones y grupos de trabajo de asociaciones gremiales y cámaras Alimentación, mantenimiento y actualización de la información en: sistemas, bases de datos y repositorios documentales (físicos y electrónicos) Evaluación del impacto regulatorio de cambios al producto implementados por el Fabricante. Mantenerse actualizado(a) sobre los cambios en el ambiente normativo y regulatorio en México, así como la oportuna comunicación de planes de adaptación y/o mitigación de riesgos.Productos de Ciencia, Investigación y Diagnóstico Veterinario
Alta de producto en sistemas (evaluación de cumplimiento regulatorio) Gestión de repositorios y bases de datos del marco normativo SENASICA aplicable Coordinación y supervisión de consultores externosOtras actividades
Gestión de pago(s) a proveedores. Cumplimiento de procesos administrativos dentro de la compañía.Conocimientos técnicos:
Profesional (con título y cédula) de Químico Farmacéutico Biólogo, Lic. en Farmacia, Lic. Bioquímica, Ing. Farmacéutico. Inglés intermedio-avanzado (escrito y hablado) Excel intermedio-Avanzado (manejo y análisis de bases de datos) Habilidades en redacción.Calificación mínima:
4 - 6 años de experiencia en asuntos regulatorios de dispositivos médicos en empresas Trasnacionales.
NOTAS
Estabilidad de 2 a 3 años en los últimos empleos. Principal motivador de un cambio, retos y aprendizaje. Cambios estructurales definidos a largo plazo.Habilidades personales:
Liderazgo Ética Organización y planificación Proactividad Atención al detalle Comunicación asertiva Gusto por aprendizaje constante-
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