Shoebar Associates
Senior Consultant
Boston Scientific Apr 2014 - Aug 2017
Senior Regulatory Affairs Specialist
Boston Scientific Dec 2008 - Apr 2014
Regulatory Affairs Specialist I and Ii
Ziopharm Oncology Mar 2008 - Oct 2008
Senior Associate, Regulatory Affairs and Quality
Sanofi Genzyme Apr 2007 - Dec 2007
Regulatory Associate
Education:
Regis College
Master of Science, Masters
College of Mount Saint Vincent
Bachelors, Bachelor of Science, Chemistry
Skills:
Regulatory Affairs Fda Quality System Medical Devices Validation Cro Pharmaceutical Industry 21 Cfr Part 11 Iso 13485 Ind V&V Pharmaceutics Capa Ce Marking Regulatory Submissions Iso 14971 Ctms Regulatory Requirements Design Control Regulations Software Documentation U.s. Food and Drug Administration Cro Management New Product Launch
Farrand Elementary School Plymouth MI 1992-1996, Gallimore Elementary School Canton MI 1996-1997, Central Middle School Plymouth MI 1997-2000, Canton H.S. Canton MI 2000-2004
Westminister Christian Academy St. Louis MO 1993-1997
Community:
Lauren Kaplan, Julie Starr, Jake Bye, Laura Bronowicz, Karrie Pigg, Tarren Clark, Margaret Margaret, Aaron Johnson, Matthew Taylor, Mike Manker, Rebekah Wiggers, Meri Marsh