Regulatory Affairs Specialist

hace 2 semanas


Bogota, Colombia bioMérieux sa A tiempo completo

Propósito Primario y objetivo General del Puesto:
Asegurar la implementación y la conformidad a leyes y regulaciones vigentes establecidas por agencia regulatoria local (INVIMA), los estándares del FDA y la directiva de la comunidad europea para la importación, comercialización, distribución de productos para diagnostico in vitro y control microbiológico.
2 Principales **Responsabilidades**:
Realizar los trámites necesarios antes el INVIMA y las entidades regulatorias nacionales a fin de mantener actualizados los registros sanitarios, certificados No requiere y las autorizaciones de funcionamiento necesarias bajo la normativa vigente para mantener disponible la oferta de productos.
Determinar el estado de cumplimiento de la normativa de la autoridad sanitaria local, lineamientos corporativos, estándares de la FDA y directrices de la comunidad europea
Asegurar el cumplimiento de la normativa local en relación a la mejora o cambios de productos comunicados por RA corporativo
Seguimiento de programa de Reactivo-Vigilancia y Tecno-Vigilancia ante la autoridad sanitaria local y de acuerdo a las directrices corporativas
Cumplir todas las funciones descritas en la Resolución 132 de 2006 y la Resolución 4002 de 2007 como Director Técnico.
Participar y contribuir al cumplimiento de los objetivos del Sistema de Gestión de la Seguridad y Salud en el Trabajo SG-SST de bioMérieux Colombia.
3 Estudios Típicos
- Experiência, Habilidades y Calificaciones:
3.1 Estudios-Experiências:

- Químico Farmacéutico/Bacteriólogo/Microbiólogo
- 5 años de experiência en asuntos regulatorios de industrias IVD/MD

3.2 Habilidades y Calificaciones:

- Conocimiento de las regulaciones colombianas aplicables para reactivos de IVD de control microbiológico y dispositivos médicos
- Conocimiento de la legislación internacional aplicable (QSR/ISO/FDA/CSA)

4 Alcance y Recursos, Indicadores Típicos de Desempeño - Scope and Resources Accountability, Typical Performance Indicators:

- Alcance y responsabilidad de recursos: Todos los productos (Reactivos de IVD, control microbiológico e instrumentos)
- Indicadores financieros (revenue, budget, etc.): N/A
- Key Performance Indicators (KPIs): Respuestas ante entes regulatorios oportunas/RA KPI Performance
- Key Contacts (internos/externos) e Interfases: todos los procesos/INVIMA/Clientes/Proveedores



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