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Regulatory Affairs Manager

hace 4 meses

Madrid, Madrid, España LHH A tiempo completo

Desde LHH Recruitment Solutions estamos buscando un/a Regulatory Affairs Manager para una empresa biotecnológica especializada en el desarrollo de test de diagnóstico.

Como Manager del área de Regulatory Affairs, la persona desarrollará la estrategia del departamento para asegurar que los productos a desarrollar cumplen los estándares regulatorios a nivel global, siendo la persona de enlace entre los organismos reguladores y los diferentes departamentos de la compañía.


Para ello asumirá, entre otras, las siguientes funciones:

  • Definición de la estrategia regulatoria de la compañía, tanto para productos actuales así como para nuevos desarrollos.
  • Elaborar, revisar y presentar la documentación necesaria frente a las autoridades correspondientes (EMA y FDA entre otras)
  • Asegurar el cumplimiento normativo para los productos de diagnóstico in vitro y los productos sanitarios, incluyendo las normas ISO y marcado CE.
  • Servir de punto de referencia de la compañía frente a las autoridades regulatorias pertinentes. Requisitos
  • Formación Universitaria en la especialización de ciencias
  • Master de especialización en el área de Regulatorio (valorable)
  • Al menos 5 años de experiencia en el desarrollo de funciones similares con procesos regulatorio de IVD
  • Experiencia previa en la implementación y certificación de normativas de calidad (ISO , ISO , ISO )
  • Experiencia trabajando con las agencias regulatorias Europeas y FDA
  • Nivel de inglés alto (imprescindible)