Mahtab Fatemi

Ms. Fatemi has over 10 years of regulatory experience in the medical device and pharmaceutical industries. Her career started in the IVD industry at BD Biosciences in San Jose, CA. At BD, she spent 7 years preparing US and international submissions for software, hardware and reagent products. While working as a regulatory affairs professional, Mahtab attended the evening program at Santa Clara School of Law, graduating in 2004. After leaving the IVD industry, she joined MAP Pharmaceuticals, a start-up pharmaceutical, which develops inhaled products for various disease states. She led the regulatory affairs department there and was responsible for US and global submissions. Mahtab relocated to the DC area in 2008 and has been consulting for various device companies since that time. She has experience with 510(k) submissions, INDs and IDEs and has drafted technical files for submission to notified bodies in the EU.

Ms. Fatemi holds a BS in Biology from UC Irvine, a MS in Physiology from Georgetown University and a JD from Santa Clara University School of Law. She is an active member of the California Bar (No. 243896) and is waiting admission to the District of Columbia Bar.