November 3, 2021 – 1 – 2pm ET
Isabella Schmitt, RAC, Proxima CRO Director of Regulatory Affairs
Isabella Schmitt is the Director of Regulatory Affairs at Proxima Clinical Research, Inc., a contract research organization focusing on assisting emerging medical device and biotech companies in regulatory, quality, and clinical development. At Proxima, Isabella is responsible for overseeing over 100+ medical device and pharma projects. Prior to joining Proxima, Isabella served as the Senior Regulatory and Quality Manager for two medical device companies, where she outlined the regulatory strategy and put together design controls and quality documentation, and as the Director of CMC and Quality at a biopharmaceutical company, where she oversaw all product development and ensured CMC regulatory strategy was sufficient for filings the US and Europe.
Outside of Proxima, Isabella is a judge, mentor, and speaker for multiple healthcare accelerators, including MedTech Innovator, TMCx, MassChallenge, gBEta, and Hatch. She also serves as a pitch coach for SXSW Pitch Competition.