Biographical Summary
 

Nancy O'Neil, RAC    

Consultant


Nancy brings over 15+ years of business experience in several capacities from the medical industry.  She started out in biochemistry research as a Research Associate focused on lysosomal storage diseases (LSD) and the progressed into business functions.  At Adams Laboratories, she was the first field representative for a line of respiratory products, not only for sales, but for distribution arrangements with area wholesalers.  After starting this new venture, she moved on to hospital based medical sales with Baxter Healthcare, IV Systems during Verne Louck's tenure when Baxter was the #1 medical company in the nation.  After that tenure, she went to distribution sales with Fisher Scientific. 

She expanded her focus after that time to working as the Training/Clinical Site Manager for a start up medical device firm (VTI), focused on a novel new IDE device for image guided surgery applications and then moved on to Millipore Corporation as an OEM Business Development Manager for North America, handling multiple regulatory, quality, manufacturing concerns for clients in the medical device/diagnostic industry.  Her tenure also included conducting a business/financial analysis for distribution options for Millipore Direct Medical Hospital Business Unit.

Since 2001, Nancy has utilized her extensive and diversified background to focus on work in Regulatory Affairs.  She has worked for several clients, including a FT yearlong contract with EPIX Medical for their first NDA submission and subsequent IND application.  Other contract clients have included work on 510 (k) to medical devices companies in the orthopedic, neurology, general medicine and cardiovascular area.

Nancy is an RAC Certified Professional through the RAPS Association and holds a Bachelor in Science from Syracuse University at Utica College.