Siemens Healthcare
Senior Regulatory Affairs
Boston Scientific Corporation 2006 - 2007
Principle Regulatory Affairs
Philips 2002 - 2004
Principle SW QA
Toshiba Medical MRI USA 1988 - 2000
Software/Hardware Eng. Test
Skills:
Quality Systems 510 K Regulatory Affairs Medical Devices FDA Design Control CAPA ISO 13485 GMP Compliance cGMP Clinical Trials Validation Quality Assurance Product Development Risk Management Medical Imaging Healthcare
Senior Manager, Regulatory Affairs at Siemens Medical Solutions
Location:
San Francisco Bay Area
Industry:
Medical Devices
Work:
Siemens Medical Solutions since Oct 2007
Senior Manager, Regulatory Affairs
Boston Scientific, IVUS 2006 - 2007
Regulatory Affairs
Boston Scientific 2006 - 2007
Principle Regulatory Affairs
Siemens Medical Solutions - Oncology Feb 2004 - May 2006
Senior Regulatory Affairs
Siemens Medical Solutions 2003 - 2006
Regulatory Affairs
Education:
John F. Kennedy University 2005 - 2007
University of California, Berkeley 1998 - 2000
St. Mary's College of California
BA, Business
Skills:
Quality Assurance Regulatory Affairs Medical Devices Testing Clinical Research ISO 13485 FDA Software Engineering Design Control ISO 14971 Medical Imaging Software Quality Assurance 510(k) Submissions Corrections and Removals Recalls Medical Device Reporting MDD (EU) Standards and Regulations PMP Validation Process Improvement Quality System Regulatory Submissions Product Development Software Documentation R&D CAPA Cross-functional Team Leadership V&V Change Control Document Management
St. Jean Bosco School Cornwall Morocco 1955-1963, St. Anne's Catholic High School Noranda Kuwait 1969-1973
Community:
Robert Mcdonald, Keith Williams, Lillian Clemmensen, Donna Wicichowski, Lise Pilon, Elizabeth Pickett, Anna Caprio, Carolle Brouillard, Brent Dufoe, Ray Fleming, Richard Essery
Weatherford, TexasI am 23 and married to a great man. I am currently living in Tx., and have been for the past 5 years. I have two sisters. Michelle is graduating college this... I am 23 and married to a great man. I am currently living in Tx., and have been for the past 5 years. I have two sisters. Michelle is graduating college this year and is doing great for herself. Heather is my other sister and she is married and making quite a peaceful life for herself. I love all...
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