Regulatory Affairs Specialist III

Encontrado en: Talent MX C2 - hace 3 semanas


Mexico City Thermo Fisher Scientific A tiempo completo

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 externos

Otras 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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