Regulatory Affairs Medical Devices
hace 4 semanas
Empresa innovadora especializada en la fabricación de productos sanitarios y de higiene hospitalaria busca incorporar la figura de Técnico / a de Regulatory Affairs, quien será responsable de garantizar el cumplimiento normativo de los productos en las áreas de biocidas, cosméticos y dispositivos médicos.
Responsabilidades:- Realizar seguimiento de cambios normativos y evaluar su impacto en los productos y procesos.
- Asegurar el cumplimiento de la normativa en biocidas, cosméticos y dispositivos médicos (medical devices).
- Gestionar la documentación técnica conforme a los reglamentos aplicables.
- Coordinar pruebas y evaluaciones necesarias para la certificación y seguridad de los productos.
- Colaborar con autoridades sanitarias, organismos notificadores y laboratorios externos.
- Apoyar en auditorías internas y externas para mantener las certificaciones requeridas.
- Grado en Farmacia, Biotecnología, Química, Ciencias de la Salud o afines.
- Mínimo 1 año de experiencia en asuntos regulatorios en el sector sanitario, Reglamento (UE) 2017 / 745 (MDR) para dispositivos médicos.
- Haber estado en contacto con la AEMPS.
- Valorable conocimientos en otros reglamentos de Biocidas y / o Cosméticos.
- Orientación a resultados y capacidad de gestión autónoma.
- Excelentes habilidades de comunicación e interlocución con organismos regulatorios.
- Atención al detalle y capacidad de análisis.
- Autonomía y flexibilidad en la gestión de tus responsabilidades.
- 3 días de teletrabajo semanal.
- Formar parte de un equipo dinámico y multidisciplinar, con impacto en la salud y la seguridad hospitalaria.
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