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Your Responsibilities Responsable de la revisión periódica de normativas regulatorias que aplican a nuestra compañía y punto de contacto con la central para reportarlo.
Dar soporte al área de Regulatory Affairs en la gestión de FSCA´s (Field Safety Corrective Actions) y preparación de QIL (Quality Information Letters) para clientes; trazabilidad y acciones relacionadas con las notas de aviso.
Registro de producto sanitario en AMEPS, de acuerdo con las directrices de su responsable, a fin de garantizar el cumplimiento de la normativa legal vigente y la implantación de la gestión de los sistemas de calidad.
Registro de producto sanitario en INFARMED.
Soporte al área de Concursos en temas relacionados con Regulatory y Calidad.
Soporte a Product management y ventas en requerimientos de cliente relacionados con el área regulatoria, incluyendo cuestionarios de evaluación de proveedores.
Preparación de ficheros de tasas de INFARMED y presentación mensual.
Your qualification 3 años de experiencia relevante en un puesto similar.
Preferiblemente Inglés nivel Intermediate.
Your competencies Capacidad Analítica Capacidad de Aprendizaje Comunicación Colaboración Trabajo en equipo Flexibilidad Orientación Cliente Iniciativa Planificación Orientación a Resultados About Olympus At Olympus, we are committed to Our Purpose of making people's lives healthier, safer and more fulfilling.
As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
For more information, visit and follow our LinkedIn account: linkedin.com/company/OlympusMedEMEA .
Seniority level Mid-Senior level Employment type Full-time Job function Legal Industries Medical Equipment Manufacturing #J-18808-Ljbffr
