Descripción y detalle de las actividades- Participate in weekly Global Product Registration meetings to understand process and documents needed for submission(s) - Gather, organize, and file registration documentation, such as registration certificates, APDL export, specific site certificates (ISO 13485, EC) - Organize Tech File documentation, i.E. - Declaration of Conformity, Master Data part number list, Clinical, Software, Risk Management, Biocompatibility, for submissions - Gather, organize, and file labeling (product, packaging, IFU/Manuals, brochures) for registration submissions - Maintain official registration regulatory files in our electronic quality/regulatory files system (i.E. - RIMSys or OneDrive) to provide history and tracking method for current and future registration submissions - Order and complete Certificate of Foreign Government (CFG) requests via FDA for export customers - Help to create memos and letters related to the export of devices for registration - Develop and maintain positive relationships with Export Sales Managers and Customer Care - Communicate to Regulatory and Export team members the most current documents available to staff - Provide excellent customer service to all internal and external customers - Generate reports for Global Product Registration metrics, i.E. - OnBase, Business Intelligence, RIMSys, OBIEE SalesExperiência y requisitos- High school diploma or higher - Proficiency with Microsoft Office Package and Adobe Acrobat - Excellent verbal and written communication skills - Requires outgoing and friendly personality for interaction with internal and external parties. - Bilingual (must speak English) - Previous Regulatory and/or Document Control experience a plusOrganizaciónENOVIS México, S.A. de C.V.GiroMaquiladora (Export.)Actividad principalManufactura aparatos ortopédicos.Número de empleados2700**Área** Auditoría**Contrato** Permanente**Turno** Diurno**Jornada** Tiempo Completo**Estudios** Titulo Profesional**Sexo** Indistinto