Technical Director Medical Devices - Regulatory Affairs

About the role

We are seeking a Regulatory Affairs and Quality Assurance specialist to lead and supervise the Technical Direction, Regulatory Affairs, Technovigilance and Quality functions for medical devices in Colombia. The role ensures full compliance with all applicable sanitary regulations and aligns local operations with the regional corporate strategy directed from Mexico.

Key responsibilities

• Lead and supervise Technical Direction, Regulatory Affairs, Technovigilance and Quality activities for medical devices in Colombia.
• Ensure compliance with Colombian sanitary requirements and INVIMA regulations.
• Act as the primary technical and regulatory liaison with INVIMA and other local health authorities.
• Coordinate with manufacturers, clients and the regional quality team to maintain product safety and regulatory conformity.
• Align local regulatory and quality processes with the corporate strategy set by the Head of RA & QA in Mexico.

Required profile

• Proven experience in regulatory affairs and quality assurance for medical devices.
• Familiarity with Colombian health authority INVIMA processes and sanitary requirements.