Regulatory Affairs Specialist Iii
hace 2 semanas
**Objetivo**:
Garantiza el cumplimiento regulatorio de los dispositivos médicos, productos de ciencia-investigación y de salud animal comercializados en México en un nível 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 experiência 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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