Connection profile

cmarcondes07

About: Degree in Pharmacy from the University of Grande Rio (RJBrasil), RA / QA professional, with specialization in Health Surveillance, from Estácio (UNESA) and master's degree in Health Surveillance from INCQS - FIOCRUZ (National Institute for Quality Control and Services); Internal auditor ISO 13485/2016 and RDC 16/2013. Specialist in regulation of medical devices (ANVISA - Brazil) and LATAM. Expertise in quality QMS in manufacturers, importers and distributors of medicines, cosmetics, sanitizers and medical devices, located in Rio de Janeiro. Professional experience of 14 years in the Regulatory area in regulatory submissions to obtain homologations at the National Health Surveillance Agency (ANVISA), as well as the development and maintenance of quality assurance systems in accordance with requirements: ANVISA, RDC 16/2013 and ISO 13485, monitoring the quality of purchased products, as well as experience in Internal and Supplier Audits; review of DMR (Device Master Record) documents; management activities National and International Regulatory Affairs; leadership and team development skills; negotiating new business strategies; applicability of ISO, CE, ANVISA, FDA standards. Experience and interface with the Clinical Research area.