Roxana
Cernescu

Senior Consultant, Quality and Regulatory Affairs


Roxana Cernescu has more than 25 years of medical device industry experience, primarily in interventional cardiology and radiology devices, including stents. 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, Russia, 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.