FDA Center for Devices and Radiological Health

Description

The Center for Devices and Radiological Health is the branch of the United States Food and Drug Administration responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices. Parent organization: Food and Drug Administration

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FDA Center for Devices and Radiological Health Employees

Employee
Years
Job
Industry
Raheel Ata Raheel Ata San Francisco Bay Area Details
Raheel Ata's FDA Center for Devices and Radiological Health Experience January 2014 - April 2014
Job M.D. Candidate at Stanford School of Medicine
Industry Medical Devices
Experience
FDA -- Center for Devices and Radiological Health  January 2014 - April 2014
Forge Realty Partners   October 2013 - December 2013
University of Texas at Dallas  August 2013 - December 2013
Advanced Polymer Research Lab   June 2011 - December 2013
Neural Engineering Laboratory   April 2012 - August 2013

Skills
Research, Medical Devices, Public Speaking, Teamwork, Healthcare, Health Policy, Hospitals, Time Management, Immunohistochemistry, PowerPoint, Microsoft Excel, Microsoft Word, Smoothies

Education
The University of Texas at Dallas   2011 — 2015
Bachelor of Science (BS), Biochemistry

The London School of Economics and Political Science (LSE)   2014 — 2014
Economics

University of Oxford   2013 — 2013
Medical Ethics

Greenhill School
High School Diploma

Stanford University School of Medicine   2015 — 2019
Doctor of Medicine (M.D.)

Daniel Caños Daniel Caños Washington D.C. Metro Area Details
Daniel Caños's FDA Center for Devices and Radiological Health Experience January 2013 - Present
Job Associate Director in the Division of Epidemiology
Industry Government Administration
Experience
FDA Center for Devices and Radiological Health   January 2013 - Present
FDA Center for Devices and Radiological Health   November 2011 - January 2013
FDA Center for Devices and Radiological Health   September 2009 - October 2011
Food and Drug Administration  May 2008 - September 2009
University of North Carolina at Chapel Hill  August 2004 - May 2008
MedStar Health  September 2001 - August 2004

Skills
Epidemiology, Research, Public Health, Biostatistics, Global Health, SAS, Program Evaluation, Data Analysis, Statistics, Literature Reviews, Clinical Trials, Clinical Research, Statistical Modeling, Prevention, Grant Writing, Clinical Study Design, Stata, Teaching

Education
University of North Carolina at Chapel Hill
Doctor of Philosophy (PhD), Epidemiology

The George Washington University   1999 — 2001
Master of Public Health (MPH), Epidemiology

University of Cincinnati   1995 — 1998
Bachelor of Arts (BA), Psychology

St. X

Patrick Weixel Patrick Weixel United States Details
Patrick Weixel's FDA Center for Devices and Radiological Health Experience August 2010 - March 2012
Job Postmarket Team Leader at FDA
Industry Government Administration
Experience
FDA  March 2012 - Present
FDA Center for Devices and Radiological Health   August 2010 - March 2012
FDA/Center for Devices and Radiological Health   September 2002 - August 2010
FDA/ Philadelphia District Office   1992 - 1993

Skills
Sterilization, Quality System..., Standards Compliance, Quality System, Medical Devices, Regulatory Requirements, CAPA, FDA, Inspection, Healthcare, Quality Auditing, Regulatory Affairs, Environmental Monitoring, Microbiology, GMP, Regulatory Submissions, ISO 13485, Validation, Biotechnology, Life Sciences

Education
Frostburg State University   1984 — 1989
Bachelor of Science (BS), Wildlife, Fish and Wildlands Science and Management

William Maisel William Maisel Washington D.C. Metro Area Details
William Maisel's FDA Center for Devices and Radiological Health Experience 2010 - Present
Job Deputy Director for Science and Chief Scientist FDA Center for Devices and Radiological Health
Industry Medical Devices
Experience
FDA Center for Devices and Radiological Health   2010 - Present

Skills
Clinical Research, Medical Devices, FDA, Medicine, Research, Biotechnology, Clinical Trials, Regulatory Affairs, Clinical Development, Infectious Diseases, Pharmaceutical Industry, Cancer, Hospitals, Laboratory, Oncology, Hardware Diagnostics, Public Health, Healthcare, Medical Education, Drug Development, Healthcare Management, Immunology

Education
Harvard School of Public Health
Master of Public Health (MPH)

Joan & Sanford I. Weill Medical College of Cornell University
Doctor of Medicine (MD)

Massachusetts Institute of Technology
Bachelor of Science (BS)

Kat Tang Kat Tang Orange County, California Area Details
Kat Tang's FDA Center for Devices and Radiological Health Experience June 2006 - August 2007
Job Clinical Project Manager | M.S. Candidate in Healthcare Decision Analysis
Industry Medical Devices
Experience
Edwards Lifesciences  June 2015 - Present
Edwards Lifesciences  October 2011 - June 2015
Advanced Biologics  August 2010 - August 2011
US Spine  June 2008 - June 2010
FDA Center for Devices and Radiological Health   June 2006 - August 2007

Skills
Biomedical Engineering, Product Launch, Clinical Research, ISO 13485, Medical Devices, FDA, Design Control, Cross-functional Team..., Product Development, Biomaterials, Project Management, Clinical Trials, Validation, CAPA, R&D

Education
University of Southern California   2014 — 2016
Master of Science (M.S.), Healthcare Decision Analysis

University of Miami   2007 — 2008
Master of Science, Biomedical Engineering

University of Miami   2003 — 2007
Bachelor of Science, Biomedical Engineering

JoAnn Brumbaugh JoAnn Brumbaugh Washington D.C. Metro Area Details
JoAnn Brumbaugh's FDA Center for Devices and Radiological Health Experience March 2012 - Present
Job Nurse Consultant FDA
Industry Medical Devices
Experience
FDA; Center for Devices and Radiological Health  March 2012 - Present

Skills
Public Speaking, PowerPoint, Customer Service, Microsoft Office, Healthcare Management, Coaching, Training, Hospitals, Leadership, Leadership Development, Social Media, Software Documentation, Strategic Planning

Education
Manor College   2002 — 2004
Legal Nurse Consultant, Legal Studies, General

Albright College
BSN, Nursing Practice

Albright College
Bachelor of Science (BS), Nursing

Michele Bonhomme Michele Bonhomme Washington D.C. Metro Area Details
Michele Bonhomme's FDA Center for Devices and Radiological Health Experience 2007 - Present
Job Epidemiologist at U.S. Food and Drug Administration
Industry Medical Devices
Experience
FDA Center for Devices and Radiological Health   2007 - Present
Johns Hopkins University  September 1994 - 1995
Centers for Disease Control and Prevention  1992 - 1994
Family Health International  1985 - 1994

Skills
Research Project..., Epidemiology, Health Communication, Data Analysis, Technical Writing, Strategic Planning, Stakeholder Analysis, Medical Informatics, Critical Thinking, Analytical Abilities, Performance Measurement, Team Leadership

Education
University of North Carolina at Chapel Hill   1988 — 1996
PhD, Epidemiology, Public Health

Oberlin College   1973 — 1977
BA, Neurosciences

Manuela Buzoianu Manuela Buzoianu Rockville, Maryland Details
Manuela Buzoianu's FDA Center for Devices and Radiological Health Experience April 2012 - Present
Job statistician
Industry Medical Devices
Experience
FDA Center for Devices and Radiological Health   April 2012 - Present
AstraZeneca / MedImmune   April 2010 - April 2012
AstraZeneca / MedImmune   April 2009 - March 2010
AstraZeneca / MedImmune   December 2007 - March 2009
Johnson & Johnson PR&D   September 2005 - December 2007

Skills
Clinical Study Design, Biostatistics, Clinical Trials, Oncology, Drug Development, Medical Devices, Survival Analysis, SAS, Statistical Programming, R, Clinical Development, SAS programming, Statistical Modeling, CDISC

Education
Carnegie Mellon University   2000 — 2005
PhD, Statistics

James Kolonay James Kolonay Washington D.C. Metro Area Details
James Kolonay's FDA Center for Devices and Radiological Health Experience September 2013 - Present
Job Technology Transfer Specialist at FDA
Industry Biotechnology
Experience
FDA Center for Devices and Radiological Health   September 2013 - Present
Penn State University  2004 - April 2012
The Institute for Genomic Research (TIGR)   July 1998 - February 2004

Skills
Intellectual Property, Technology Transfer, Licensing, Patents, Technology..., Contract Negotiation, Materials Transfer, Biopharmaceuticals, Drug Discovery, Medical Software, Medical Devices, Biochemistry, Molecular Biology, Bioinformatics, Genomics, Data Analysis, Life Sciences, Biotechnology, Commercialization, Genetics

Education
FAES

FAES

The Johns Hopkins University
Doctor of Philosophy (Ph.D.), Biochemistry