Resumes
Resumes
Chief Executive Officer | Principle Consultant
View pageLocation:
12407 Rousseau Ter, North Potomac, MD 20878
Industry:
Medical Devices
Work:
Theranova, Llc Sep 1, 2016 - Mar 2018
Executive Regulatory Affairs Advisor
Arina Consulting Sep 1, 2016 - Mar 2018
Chief Executive Officer | Principle Consultant
Fda Jun 1, 2011 - Sep 2016
Senior Program Manager, Emergency Preparedness and Medical Countermeasures Program
Fda Oct 2006 - Jun 2011
Biomedical Engineer
Seracare Mar 2005 - Oct 2006
Qa Senior Manager
Executive Regulatory Affairs Advisor
Arina Consulting Sep 1, 2016 - Mar 2018
Chief Executive Officer | Principle Consultant
Fda Jun 1, 2011 - Sep 2016
Senior Program Manager, Emergency Preparedness and Medical Countermeasures Program
Fda Oct 2006 - Jun 2011
Biomedical Engineer
Seracare Mar 2005 - Oct 2006
Qa Senior Manager
Education:
Harvard T.h. Chan School of Public Health 2014 - 2015
Georgetown University 2011 - 2013
Virginia Tech 1996 - 2000
Georgetown University 2011 - 2013
Virginia Tech 1996 - 2000
Skills:
Fda
Medical Devices
Biomedical Engineering
Life Sciences
Biotechnology
U.s. Food and Drug Administration
Gmp
Clinical Trials
Quality System
Capa
Validation
Sop
Quality Assurance
Iso 13485
R&D
Design Control
21 Cfr Part 11
Regulatory Affairs
Lifesciences
Standard Operating Procedure
Research and Development
Corrective and Preventive Action
Regulatory Strategy Development
Medical Devices
Biomedical Engineering
Life Sciences
Biotechnology
U.s. Food and Drug Administration
Gmp
Clinical Trials
Quality System
Capa
Validation
Sop
Quality Assurance
Iso 13485
R&D
Design Control
21 Cfr Part 11
Regulatory Affairs
Lifesciences
Standard Operating Procedure
Research and Development
Corrective and Preventive Action
Regulatory Strategy Development
Interests:
Medical Countermeasures
Medical Devices
Medical Devices
Mcm Sr. Program Manager At Fda
View pagePosition:
MCM Sr. Program Manager at FDA
Location:
Washington D.C. Metro Area
Industry:
Medical Devices
Work:
FDA since Jun 2011
MCM Sr. Program Manager
FDA Oct 2006 - Jun 2011
Biomedical Engineer
Seracare Mar 2005 - Oct 2006
QA Sr. Manager
Digene Corporation Jun 2001 - Mar 2005
Instrumentation Engineer
MCM Sr. Program Manager
FDA Oct 2006 - Jun 2011
Biomedical Engineer
Seracare Mar 2005 - Oct 2006
QA Sr. Manager
Digene Corporation Jun 2001 - Mar 2005
Instrumentation Engineer
Education:
Georgetown University 2011 - 2013
Graduate Certificate, Biohazardous Threat Agents & Emerging Infectious Diseases Virginia Polytechnic Institute and State University 1996 - 2000
Engineering Science and Mechanics, Biomechanics
Graduate Certificate, Biohazardous Threat Agents & Emerging Infectious Diseases Virginia Polytechnic Institute and State University 1996 - 2000
Engineering Science and Mechanics, Biomechanics
Skills:
FDA
Medical Devices
ISO 13485
Biomedical Engineering
Validation
Biotechnology
Lifesciences
R&D
GMP
Design Control
21 CFR Part 11
Quality System
Medical Devices
ISO 13485
Biomedical Engineering
Validation
Biotechnology
Lifesciences
R&D
GMP
Design Control
21 CFR Part 11
Quality System
Interests:
Medical Countermeasures, medical devices