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 ope

📌 Regulatory affairs, Medical devices, Sanitary registration procedures (Bogotá, D.C.)
🏢 Michael Page Colombia
📍 Bogotá, D.C.