Sharon Sax

Sharon Sax has extensive experience in the field of clinical and regulatory consulting for medical device companies. Sharon is currently working as a Clinical and Regulatory Consultant at their own company, Sharon Sax - Clinical & Regulatory Consultant, starting from October 2021.

Prior to this, Sharon held the position of VP Clinical, Regulatory and QA at Pi-Cardia from February 2013 onwards. Their role involved establishing and overseeing the clinical and regulatory department for a cardiac pre-market approval product. Sharon was also responsible for strategic planning, execution, and managing all quality aspects of the company.

Before Pi-Cardia, Sharon worked as VP Clinical Affairs at Endospan Ltd. from May 2011 to February 2013. Sharon played a crucial role in building and managing the clinical department for three pre-market approval products in the vascular surgery area. Additionally, they handled regulatory strategy planning and communication with Notified Bodies and FDA.

Sharon's earlier experience includes working as a Clinical Trials Director at Ventor Technologies / Sr. Manager of Clinical Affairs at Medtronic Ventor from 2008 to 2011. Sharon served as a Clinical Trials Manager at TopSpin Medical from February 2004 to March 2008 and as a Clinical Specialist at Florence Medical in 2003.

Sharon started their career at Optonol, where they worked as a Clinical Operations Manager from March 2000 to January 2003.

Overall, Sharon Sax has amassed valuable expertise in clinical and regulatory consulting, quality management, and clinical affairs throughout their career in the medical device industry.

Sharon Sax completed their bachelor's degree in Pharmacy from The Hebrew University of Jerusalem between 1994 and 1998. Sharon then pursued further education and obtained a Master's degree in Management (MsM) from New York University - Polytechnic School of Engineering, completing it between 2000 and 2001.