Desired Experience
Experience in Regulatory Affairs or the medical device industry
Experience in sanitary registration procedures and filings before INVIMA
Acerca de nuestro cliente
An organisation within the medical devices industry.
Descripción
Regulatory Affairs & Technical Direction
Ensure compliance with all technical and sanitary requirements applicable to the operation.
Oversee storage, distribution, and commercialization conditions for all products.
Attend to and participate in inspections and site visits conducted by health authorities.
Keep all mandatory Technical Direction documentation updated.
Manage sanitary registrations, renewals, modifications, and other filings before INVIMA.
Prepare, review, and submit regulatory dossiers and documentation.
Track requirements, requests, and official communications from health authorities.
Maintain updated control of permits, registrations, and expiration dates.
Evaluate regulatory changes and communicate their operational impact to relevant departments.
Coordinate with manufacturers to obtain and review required technical and regulatory documentation.
Technovigilance & Post-Market Surveillance
Guide the company's Technovigilance Program.
Manage and evaluate complaints, adverse events, and incidents related to medical devices.
Monitor health alerts, recalls, and Field Safety Corrective Actions (FSCAs).
Coordinate root-cause investigations with manufacturers and maintain full document traceability.
Quality Management System (QMS)
Maintain and continuously improve the Quality Management System (QMS).
Coordinate CAPA (Corrective and Preventive Actions), non-conformities, deviations, change control,



and risk management processes.
Plan and coordinate internal audits, as well as audits by manufacturers, clients, and health authorities.
Track audit findings and verify the effectiveness of implemented corrective actions.
Ensure proper control and updates of procedures and operational records.
Perfil 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 ***** / ISO **** 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 Ofrecemos
Attractive monthly salary
Opportunity to work within the medical devices industry
#J-*****-Ljbffr

📌 Regulatory Affairs, Medical Devices, Sanitary Registration Procedures (Bogotá)
🏢 Michael Page Colombia
📍 Bogotá