Vital Connect, Inc.
Vice President Quality and Regulatory
Eneura
Senior Director Compliance and Regulatory
Spinal Modulation Nov 2007 - Mar 2009
Quality Director
Advanced Bionics Jun 2006 - Jul 2007
Quality Director
Imetrikus Mar 2005 - Jun 2006
Compliance Director
Education:
University of California, Berkeley 1984 - 1987
Bachelors, English, Chemistry
Lynbrook High School
Skills:
Iso 13485 Fda Capa Quality System Medical Devices Validation Quality Assurance Design Control Iso 14971 Cross Functional Team Leadership Product Development Manufacturing 21 Cfr Part 11 Iso Gmp Quality Management Regulatory Requirements Start Ups V&V Change Control Software Documentation Process Improvement Regulatory Affairs Quality Auditing Document Management Supplier Quality Auditing Ce Marking Biotechnology Root Cause Analysis Fmea Sop Continuous Improvement 21 Cfr Medical Device Directive Complaint Management Risk Management