Roxana’s background includes implementation of quality management systems; auditing organizations in accordance with ISO 13485, MDD 93/42/EEC, FDA QSR, and CMDR and MDR requirements; compilation of technical documentation for CE Marking; developing global regulatory strategies; and performing international regulatory research.
Prior to joining EMERGO, Roxana held quality and regulatory management positions at several small- and medium-sized medical device companies. Her responsibilities comprised the fulfillment of a compliant quality management system, regulatory strategy, and product approvals in Europe (CE Mark), Australia, Brazil, Canada, USA, China, South Korea, Taiwan, and others. As a Senior QA/RA Consultant for EMERGO, Roxana has accomplished more than 100 projects related to various quality and regulatory topics.