Joseph Ostendorf, RAC

Joseph Ostendorf, RAC has over 15 years of experience in Regulatory Affairs. Joseph began their career in 2004 as a Technical Writer Intern at Boston Scientific, where they contributed independently and collaboratively in project teams, writing, revising, organizing, and editing test methods, product specifications, protocols, and reports for a class III drug eluting stent system. In 2005, they were promoted to Specialist, Regulatory Affairs, where they managed class II and class III regulatory submissions for products in the U.S. and in international markets. Joseph then moved to Zimmer in 2008, where they participated as a CTM on a new class III hip development project and managed the up classification of five class III hip and knee design dossiers. In 2009, they joined Biotronik as a Specialist, Regulatory Affairs, where they managed all class III supplements and amendments related to one family of Implantable Cardioverter-Defibrillators (ICD). In 2010, they joined Waters as a Principal Regulatory Affairs Specialist, managing all the worldwide submissions of the Clinical Business Organization and representing the Regulatory Affairs function in cross-functional development teams. In 2012, they started their own consulting business, Ostendorf Consulting, where they served as Manager and Principal Consultant. In 2018, they joined Electromed, Inc. as Director of Regulatory Affairs, and in 2019, they joined Holaira, Inc. as Regulatory Affairs Manager and Regulatory Affairs & Quality Systems Manager.

Joseph Ostendorf received their BS in Scientific & Technical Communication from the University of Minnesota in 2004. Prior to that, they attended Saint John's University from 1999 to 2000, studying Biology and Chemistry. In 2014, they obtained their Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS).