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Quality & Regulatory Specialist (Medical Devices)
hace 2 semanas
At Getinge we have the passion to perform
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally.
At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to improve clinical results and optimize workflows.
Every day we collaborate to make a true difference for our customers - and to save more lives.Are you looking for an inspiring career? You just found it.
Responsable de dar soporte al cumplimiento y seguimiento de los requisitos regulatorios para la comercialización de los productos de la compañía en México y CAMCAR (Centroamérica y Caribe), de acuerdo a la Normatividad Nacional e Internacional vigente, así como la regulación aplicable a MAQUET Mexicana (Getinge México).
Responsable de dar soporte para el diseño, desarrollo, implementación, administración y mantenimiento del Sistema de Gestión de Calidad en MAQUET Mexicana (Getinge México), alineado a la Regulación Sanitaria nacional, internacional y al Sistema de Gestión de Calidad global de Getinge.
Responsable Sanitario para garantizar la calidad de los productos comercializado por Maquet Mexicana (Getinge México).**
Principales Funciones y Responsabilidades
- Revisa y validar los dossiers sanitarios de acuerdo a los requisitos regulatorios vigentes, dando seguimiento de las actividades necesarias, revisando el cumplimiento de requisitos legales y técnicos, desde el sometimiento hasta la aprobación de registros nuevos, prórrogas, modificaciones de registro, correcciones y consultas.
- Autorizar etiquetas de producto acorde con los procedimientos internos y normatividad aplicable.
- Vigilar el control adecuado de la documentación regulatoria, así como de la documentación relacionada con la calidad, para dar seguimiento y contar con rastreabilidad necesaria y garantizar el cumplimiento de los requerimientos regulatorios y de calidad.
- Brindar seguimiento y apoyar los planes de cumplimiento a las condiciones de registros otorgadas en tareas de tecnovigilancia como bloqueo, retiro, eliminación, liberación, entre otras que garanticen el mantenimiento y la comercialización oportuna del producto y manejo de riesgos acorde con las políticas, procedimientos internos y la legislación sanitaria.
- Gestionar permisos de importación y plazos para agote de existencias comunicando con oportunidad las acciones a implementar derivados de estos.
- Dar soporte en la comunicación y ejecución de acciones de campo, llevando a cabo el reporte, seguimiento y cierre de estos ante las fábricas y Autoridades Sanitarias cuando así se requiera.
- Dar soporte en la comunicación y ejecución de las quejas de producto, llevando a cabo el reporte de estas ante las Autoridades Sanitarias cuando así se requiera y/o en las plataformas que dispone Getinge.
- Gestionar permisos, avisos de publicidad y revisión de materiales publicitarios acorde con procedimientos establecidos y la regulación sanitaria vigente.
- Apoyar al cumplimiento en el proceso de tecnovigilancia
- Coordinar y apoyar en la distribución de documentos al área comercial necesarios para procesos de licitaciones o marketing.
- Dar apoyo para la gestoría de trámites, al establecimiento de procedimientos y mejora de procesos del área regulatoria y del SGC de Maquet Mexicana (Getinge Mexico) y el SGC Corporativo.
- Fungir como backup del responsable del área, cuando así corresponda.
- Auxiliar en los procesos de importación requeridos por el área de Comercio Exterior para la correcta liberación de productos en el Sistema correspondiente.
- Emitir indicadores de seguimiento de registros, acciones de campo, liberación de producto
Educación y requisitos
Profesional Ingeniería Biomédica, Ingeniería Química/Bioquímica, Químico Farmacéutico, Químico Fármaco Biólogo con experiência documentada en la Importación, Distribución y Almacenamiento de Dispositivos Médicos.
Antecedentes Previos y Experiência Laboral
Mínimo 3-5 años de experiência en cargos afines y empresas de similar tamaño y complejidad, deseable en el sector de Comercio de Dispositivos Médicos, Productos Farmacéuticos, o Reactivos de Diagnóstico.
Conocimiento y experiência en
Conocimiento e interpretación de Regulación Sanitaria, LGS, RIS, Reglamento de Publicidad de Insumos para la Salud, NOM-137-SSA1, NOM-240-SSA1, NOM-241-SSA1 vigentes, Buenas Prácticas de Fabricación, Buenas Prácticas de Almacenes de Depósito y Distribución; Acuerdos DOF y Acuerdo de trámites, Guías mexicanas para Registro y Modific
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