Bluebird Consulting
Owner
Vascular Solutions Jul 2010 - Dec 2011
Senior Director, Regulatory Affairs and Clinical Research
Acorn Cardiovascular Jan 2008 - Jun 2010
Vice President, Clinical and Regulatory Affairs
Angioscore 2003 - 2007
Director, Clinical and Regulatory Affairs
Medtronic 2003 - 2004
Senior Clinical Project Manager
Education:
Minnesota State University, Mankato 1989 - 1992
Bachelors, Bachelor of Science, Biotechnology
Armstrong High School 1984 - 1987
Skills:
Clinical Research Medical Devices Fda Iso 13485 Cardiac 510 K Qsr Ce Marking Quality System Regulatory Affairs Regulatory Submissions Biotechnology Cardiology Iso 14971 Clinical Trials Capa Gmp Design Control Product Development Clinical Development Capital Equipment Market Development R&D V&V Interventional Cardiology Commercialization Hardware Diagnostics Lifesciences Sop Biomedical Engineering Product Launch Pma Orthopedic Life Sciences
University Park Elementary School Salinas CA 1980-1983, Prunedale Elementary School Salinas CA 1983-1988, Gambetta Middle School Castroville CA 1988-1989