Beaver-Visitec International, Inc. (Bvi)
Senior Director, Regulatory and Medical Affairs
R2 Medtech Regulatory Clinical & Quality
President, Founder
Histosonics Inc.
Vice President, Clinical, Quality and Regulatory
Education:
Grace College & Seminary 2012 - 2013
Master of Science, Masters
Skills:
Medical Devices Cross Functional Team Leadership U.s. Food and Drug Administration Iso 13485 Product Development Business Process Improvement Leadership Quality System Design Control
Stryker Jan 2016 - 2016
Director, Regulatory and Quality and Clinical Business Portfolio
Stryker Mar 2010 - Jan 2015
Director, Regulatory and Clinical and Professional Affairs and Compliance Officer
Stryker 2008 - 2010
Regulatory and Clinical Affairs Manager
Stryker 2008 - 2010
Regulatory Affairs Analyst
Haller Rowe & Haviland Ophthalmology Dec 2003 - 2008
Practice Manager
Education:
Grace College & Seminary 2012 - 2013
Master of Science, Masters
Spring Arbor University 2002 - 2004
Bachelors, Bachelor of Arts, Management
Sioux Falls College 1982 - 1982
Bachelors, Bachelor of Science, Nursing
Skills:
Regulatory Affairs Fda Medical Devices Iso 13485 Capa Design Control Quality System Validation Gmp V&V 21 Cfr Part 11 Regulatory Submissions Cross Functional Team Leadership Technical Clinical and Surgical Ophthalmology