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Manuel
Regulatory Affairs Analyst
Contact
Competencies
Experiencia demostrada en INVIMA sanitary registrations (new, renewal, modification).
Experiencia demostrada en Decree 4725 of 2005.
Experiencia demostrada en Technovigilance (Res. 4816 of 2008).
Experiencia demostrada en Technical dossier review.
Experiencia demostrada en Medical device risk classification.
Education
Languages
Summary
Regulatory Affairs Analyst buscando nuevas oportunidades
Experience
Regulatory Affairs Analyst
Prepare, submit, and follow up on INVIMA procedures for medical devices: new sanitary registrations, renewals, and modifications under Decree 4725 of 2005.. Compile and review technical dossiers: risk classification, certificates of free sale, manufacturer quality certificates, labeling, and instructions for use.. Support the company's technovigilance program (Resolution 4816 of 2008), including management and reporting of adverse events and incidents.. Monitor changes in Colombian health regulations and maintain the regulatory status database of the product portfolio.. Act as liaison with foreign manufacturers and internal areas to gather documentation and respond to INVIMA requirements on time.
Biomedical Engineering Assistant
Supported accreditation and quality compliance activities, preparing and organizing technical and regulatory documentation for biomedical equipment.. Managed traceability, inventory, and control of biomedical equipment and spare parts across multiple healthcare facilities in Bogotá.. Handled supplier follow-up, billing management, and coordination with different areas of the organization.
Biomedical Engineering Intern
Monitored preventive and corrective maintenance and calibration schedules, ensuring compliance with quality standards.. Participated in accreditation processes and kept equipment technical records and inventories up to date.. Assisted in equipment decommissioning and renewal processes, coordinating with technicians and suppliers.