Position:
Sr. Director of Clinical and Regulatory Affairs at Spectranetics
Location:
Colorado Springs, Colorado Area
Work:
Spectranetics
since Jul 2010
-
Sr. Director of Clinical and Regulatory Affairs
AGA Medical
Oct 2003 - Jun 2010
-
Director, Regulatory Affairs
Vascular Solutions
2001 - 2003
-
Regulatory Associate
Education:
Northeastern University 2008 - 2011
Master of Science, Regulatory Affairs - Drugs, Biologics and Medical Devices
University of Minnesota-Duluth
BS, Chemistry
Skills:
Medical Devices, Regulatory Affairs, FDA, ISO 13485, Design Control, PMA, CAPA, V&V, Quality System, ISO 14971, Clinical Trials, Validation, Regulatory Submissions, Sop, GMP, GLP, GCP, Lifesciences, CE marking, Promotional and Labeling Materials, Team Leadership