Carolina Oviedo

Carolina Oviedo is a seasoned professional in regulatory affairs and quality auditing, with extensive experience at Establishment Labs since November 2015, where roles have included Principal Regulatory Affairs Specialist and Regulatory Affairs Executive. Carolina is a lead auditor for ISO 13485:2016, ISO 9001:2015, ISO 14001, and BPM, possessing in-depth knowledge of FDA, CE Mark regulations, and ISO 14971. In addition to current responsibilities, Carolina has been self-employed as an Independent QA/RA Auditor and Consultant since April 2018, focusing on quality and regulatory standards in the medical devices industry. Previous experience includes roles at Punto Rojo S.A., as an Environmental and Quality Engineering Assistant, and as a Chemical Laboratory Technician, with a foundation in both Analytical Chemistry from Universidad de Costa Rica and ongoing studies in Business Administration and Management at Universidad Estatal a Distancia de Costa Rica.