Background
Alexandra specializes in both US FDA and international regulatory strategy, writing regulatory submissions, development and maintenance of technical and regulatory documentation, conducting systematic literature reviews, and performing gap analyses. She leads and supports regulatory projects from regulatory strategy assessments through full submission writing and communications with the FDA and Notified Bodies. She leads and supports projects including Clinical Evaluation Reports (CERs), Technical Documentations, 510(k)s, Pre-Submissions, De Novos, Investigational Device Exemptions (IDE)s, and Premarket Approval (PMA)s. She leads and supports regulatory projects across diverse therapeutic areas including orthopedic, spine, neurology, wound care, dermal fillers, and cardiovascular devices.
Education
Alexandra received her Bachelor of Science from Gettysburg College in Biochemistry and Molecular Biology and received a Master of Science in Biotechnology from Johns Hopkins University, concentrated in Regulatory Affairs. Alexandra is also RAC-certified in medical device regulatory affairs.
Experience
Alexandra has over 8 years of experience in the biotechnology industry and regulatory affairs. Before joining MCRA in 2021, Alexandra worked in viral vector product development at a privately held biotechnology company.
Overview
Alexandra has over 8 years of experience in the biotechnology industry and medical device regulatory affairs. She has extensive experience navigating both US FDA and international regulatory affairs, specializing in orthopedic, spine, neurology, wound care, dermal filler, and cardiovascular product areas. At MCRA, Alexandra leads and supports regulatory strategy and submissions. Her primary roles include managing the development of regulatory submissions, development of overall regulatory strategy, and communicating with regulatory bodies with clients.