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Este puesto será responsable de gestionar proyectos desde el desarrollo inicial hasta el lanzamiento, asegurando que se cumplan los objetivos, plazos y presupuestos del proyecto, manteniendo alineación con la estrategia de la empresa y los requisitos normativos. El candidato ideal poseerá sólidas habilidades en gestión de proyectos, un conocimiento profundo de la industria biotecnológica o de dispositivos médicos, y la capacidad de obtener resultados mediante liderazgo, organización y comunicación efectiva.\r\nResponsabilidades principales:\r\n Gestionar equipos de proyecto multifuncionales a través de I+D, Asuntos Regulatorios, Clínicos, Calidad, Operaciones y funciones comerciales para entregar productos IVD/diagnósticos desde la viabilidad hasta la comercialización. \r\n Elaborar y mantener planes de proyecto, cronogramas y presupuestos integrales, rastreando hitos, dependencias y entregables. \r\n Supervisar e informar sobre el estado del proyecto, riesgos e incidencias, proporcionando actualizaciones claras a las partes interesadas del proyecto y al liderazgo superior. \r\n Coordinar recursos y alinear prioridades entre departamentos internos para apoyar la ejecución oportuna y eficiente del proyecto. \r\n Apoyar actividades de preparación para presentaciones regulatorias, asegurando que los proyectos cumplan con las normas regulatorias y de calidad aplicables (por ejemplo, FDA, ISO 13485). \r\n Facilitar reuniones regulares del proyecto, incluyendo actualizaciones del equipo, revisiones de riesgos y sesiones de resolución de problemas. \r\n Ayudar en la gestión de proveedores y socios externos involucrados en desarrollo, fabricación u otras actividades relacionadas con el proyecto. \r\n Contribuir a iniciativas de mejora continua en procesos, herramientas y metodologías de gestión de proyectos. \r\n Mantener documentación del proyecto precisa y apoyar procesos de gobernanza, incluyendo revisiones de proyecto y toma de decisiones por etapas.\r\n Requisitos\r\nCalificaciones:\r\n Título universitario en Ciencias de la Vida, Ingeniería, Negocios o campo relacionado; se prefiere título avanzado (MS, MBA). \r\n 5 a 8 años de experiencia en gestión de proyectos en la industria biotecnológica, de diagnósticos o dispositivos médicos, con enfoque en desarrollo de productos en un entorno regulado. \r\n Conocimiento sólido de las vías regulatorias, sistemas de calidad (por ejemplo, ISO 13485) y procesos de comercialización de productos IVD o dispositivos médicos. \r\n Demostrada capacidad para gestionar equipos de proyecto multifuncionales y entregar proyectos a tiempo y dentro del presupuesto. \r\n Se valora altamente la experiencia en la industria de Ciencias de la Vida/IVD. \r\n Se prefiere fuertemente la certificación PMP o formación formal en gestión de proyectos. \r\n Excelentes habilidades organizativas, de liderazgo y relaciones interpersonales. \r\n Capacidad para trabajar eficazmente en un entorno dinámico y acelerado con prioridades cambiantes.\r\n Habilidades y competencias preferidas:\r\n Experiencia apoyando lanzamientos globales de productos y gestionando equipos distribuidos o multi-sitio. \r\n Familiaridad con software y herramientas de gestión de proyectos. \r\n Conocimiento de metodologías de desarrollo Agile o Stage-Gate. \r\n Fuertes capacidades de resolución de problemas, pensamiento crítico y toma de decisiones. \r\n Es un plus tener experiencia previa trabajando con socios externos y gestionando relaciones con proveedores.\r\n Beneficios\r\n Seguro médico, dental y de visión integral.\r\n Plan 401(k) con generosas contribuciones de la empresa.\r\n Política flexible de tiempo libre pagado (PTO).\r\n Beneficios adicionales sustanciales.\r\n \r\nDeclaración de Igualdad de Oportunidades: Somos un empleador que ofrece igualdad de oportunidades y nos comprometemos con la inclusión y la diversidad. 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