Guardar empleo Back to Search Descripción Resumen Empleos Similares Fecha de publicación 17/09/2026Experience in Regulatory Affairs or the medical device industryExperience in sanitary registration procedures and filings before INVIMAAcerca de nuestro clienteAn organisation within the medical devices industry.Descripción· Regulatory Affairs & Technical Directiono Ensure compliance with all technical and sanitary requirements applicable to the operation.o Oversee storage, distribution, and commercialization conditions for all products.o Attend to and participate in inspections and site visits conducted by health authorities.o Keep all mandatory Technical Direction documentation updated.o Manage sanitary registrations, renewals, modifications, and other filings before INVIMA.o Prepare, review, and submit regulatory dossiers and documentation.o Track requirements, requests, and official communications from health authorities.o Maintain updated control of permits, registrations, and expiration dates.o Evaluate regulatory changes and communicate their operational impact to relevant departments.o Coordinate with manufacturers to obtain and review required technical and regulatory documentation.· Technovigilance & Post-Market Surveillanceo Guide the company's Technovigilance Program.o Manage and evaluate complaints, adverse events, and incidents related to medical devices.o Monitor health alerts, recalls, and Field Safety Corrective Actions (FSCAs).o Coordinate root-cause investigations with manufacturers and maintain full document traceability.· Quality Management System (QMS)o Maintain and continuously improve the Quality Management System (QMS).o Coordinate CAPA (Corrective and Preventive Actions), non-conformities, deviations, change control, and risk management processes.o Plan and coordinate internal audits, as well as audits by manufacturers, clients, and health authorities.o Track audit findings and verify the effectiveness of implemented corrective actions.o Ensure proper control and updates of procedures and operational recordsPerfil buscado (h/m)Required Knowledge, Skills, and Experience:Education* Degree: Professional degree in Biomedical Engineering, Bacteriology, Microbiology, Industrial Engineering, Pharmaceutical Chemistry, Health Sciences, or related field-provided the candidate meets all applicable legal requirements to practice as a Technical Director in Colombia.Experience* Minimum 5 years of experience in Regulatory Affairs, Quality Assurance, or the medical device industry.* Demonstrable experience in sanitary registration procedures and filings before INVIMA.* Experience in Technovigilance and product complaint management.* Experience in Quality Management Systems (QMS) and audit execution.* Desirable: Prior experience in medical device importing and distributing companies.Knowledge* Colombian healthcare regulations applicable to medical devices.* INVIMA requirements and administrative procedures.* Technovigilance and post-market surveillance frameworks.* Quality Management Systems (ISO 13485 / ISO 9001 standards).* CAPA methodologies, risk management, and change control.* Audit management and document control systems.* English Proficiency: Intermediate/Advanced (B2/C1) for effective communication and technical documentation review with international manufacturers.Qué OfrecemosAttractive monthly salaryOpportunity to work within the medical devices industryIf you meet the requirements and are interested in this role, we encourage you to applyContactoDaniela LascanoIngresar referencia para vacanteJN-092026-7106643Resumen de empleoSectorHealthcare & Life SciencesSub SectorRegistrosSectorHealthcare / PharmaceuticalUbicaciónBogotáTipo de TrabajoTemporalNombre del consultorDaniela LascanoJob ReferenceJN-092026-7106643
