Position:
Manager, Regulatory Affairs at Covidien
Work:
Covidien
- Energy Devices (Electrosurgery, Ablation, Ultrasonic) since Dec 2006
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Manager, Regulatory Affairs
TZ Medical
May 2002 - Dec 2006
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Regulatory/Engineer
TZ Medical
Sep 1999 - Apr 2000
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Regional Sales Manager
Education:
San Diego State University-California State University 2005 - 2009
Master of Science (M.S.), Regulatory Affairs
Brigham Young University
Bachelor of Business Administration (BBA), Business Administration and Management, General
Skills:
FDA, Regulatory Affairs, Medical Devices, Regulatory Submissions, CAPA, GMP, Pharmaceutical Industry, Change Control, Validation, Regulatory Requirements, Sop, Clinical Trials, 21 CFR Part 11, Quality System, Biotechnology, eCTD, Clinical Development, Lifesciences, Biologics, GCP, MS Project, Microsoft Word, Microsoft Excel, SharePoint, InfoPath, Minitab, Oracle Agile PLM, Zinc
Certifications:
Regulatory Affairs Certified, Regulatory Affairs Professional Society
Certified Biomedical Auditor, American Society for Quality
Six Sigma Green Belt, Covidien Operational Excellence