Eva Caruso

Eva Caruso is a seasoned regulatory affairs specialist who joins MCRA Japan from our parent company, MCRA, LLC., where she worked as a cardiovascular regulatory affairs associate. Eva has authored and contributed to work across the FDA’s CDRH and CDER submissions, clinical evaluation reports, quality assurance documents and internal regulatory strategy resource documents.  

Since joining MCRA Japan’s Project Management team in April of 2023, Eva has expanded her scope to encompass business development, proposal development and ongoing project management. Her primary focus lies in bridging the gap between foreign manufacturers and the intricate PMDA regulatory pathway, leveraging her expertise to provide clear and concise guidance. She specializes in relating PMDA requirements to those of the FDA and EU MDR, offering a familiar frame of reference for businesses seeking entry into the Japanese market.