Illumina Jun 2014 - Jul 2015
Senior Manager, Regulatory Affairs
Illumina Jun 2014 - Jul 2015
Associate Director, Regulatory Affairs
Hologic (Formerly Gen-Probe) Oct 2007 - Jun 2014
Senior Manager, Regulatory Affairs
Integra Neurocare 1998 - 1999
Regulatoy Affairs Specialist
Education:
University of Redlands
Masters, Business Administration, Management, Business Administration and Management
San Diego State University
Bachelors, Bachelor of Business Administration
Skills:
Fda Biotechnology Regulatory Affairs Medical Devices Regulatory Submissions Gmp Validation Capa Iso 13485 Ivd Life Sciences Ind V&V Design Control Technology Transfer Sop Glp Lifesciences Iso 14971 Pma 21 Cfr Part 11 Change Control Molecular Diagnostics
1045 Newport Ctr Ave #1035, Newport Beach, CA 92660 1035 Newport Ctr Dr, Newport Beach, CA 92660 1045 Newport Ctr Dr, Newport Beach, CA 92660 (949)6447877
Jody Fleming (1969-1973), Joseph Simon (2002-2006), K Smith (1985-1990), Sanford Boyce (1989-1993), Stephanie Pinckert (1979-1980), Penny Buckner (1972-1976)
Jody Fleming (1988-1992), Matt Phillips (1981-1985), Jayne Bradley (1974-1978), Kathryn Efinger (1981-1985), Bonita Maine (1972-1976), Scott Williams (1981-1985)