Gerente de Calidad para Colombia y DX countries
Core
Ensuring Quality Management System compliance with local and international regulations for medical devices in Colombia and DX countries, serving as the Technical Director before health authorities.
Role type
Quality Manager / Technical Director for Medical Devices
Builds
Regulatory compliance and quality assurance for Abbott Diabetes Care products
Domain
Healthcare / Medical Devices / Regulatory Affairs
Deliverable
client delivery
Required skills
Quality Management Systems, regulatory compliance, supplier and distributor management, product traceability, corrective and preventive actions, complaint handling, technical advisory to legal representatives
Preferred skills
experience in medical device regulatory frameworks, managing third-party logistics, leadership in matrix environments
Technologies
Veeva
Responsibilities
Establish and maintain the quality management system at the commercial affiliate site, serve as the main contact for the health authority (INVIMA) regarding medical devices, monitor local regulations and emerging regulatory changes, manage supplier and distributor selection and approval, ensure product traceability from importation to commercialization, handle product returns, quality holds, and stop shipments, coordinate with foreign trade areas for product investigations, monitor promotional material compliance, ensure proper storage and distribution conditions, manage adverse incident reporting and market removal procedures
Seniority
Manager, hands-on IC
