Chief Regulatory Strategist @ (April 2022 - September 2022)
Vice President of Security Services @ (June 2021 - April 2022)
Global Regulatory Advisor - Medical Device Cybersecurity @ (November 2019 - April 2022)
RAPS Faculty @ (March 2019 - Present)
Vice President of Cyber Program Initiatives @ (June 2018 - November 2019)
Director, Regulatory Affairs Cybersecurity @ (February 2018 - June 2018)
Principal Regulatory Affairs Specialist @ (March 2015 - February 2018)
Regulatory Affairs Associate Analyst @ (September 2013 - February 2015)
Associate Regulatory Affairs Analyst @ (October 2012 - September 2014)
Senior Regulatory Affairs Representative @ (April 2010 - October 2012)
Associate Scientist @ ADMETRx (September 2008 - April 2010)
Michelle Jump Education
University of Southern California
MS (Regulatory Science)
2008-2011
California State University, Channel Islands
MS (Biotechnology)
2007-2008
UC Santa Barbara
BS (Ecology, Evolution, Marine Biology)
1994-1998
Michelle Jump Skills
21 CFR Part 11
510 K
Assurance Cases
Biotechnology
CAPA
Clinical Development
Cyber-security
Design Control
FDA
GLP
GMP
Human Factors
ISO 13485
ISO 14971
Interoperability
Medical Devices
Mobile Applications
Product Development
Quality Assurance
Quality System
Quality Systems
R&D
Regulatory Affairs
Risk Management
SDLC
SOP
Software
Standard Operating Procedure (SOP)
U.S. Food and Drug Administration (FDA)
V&V
Validation
Wireless Devices
Strategy
Development
Regulatory
Cyber Security
U.S. Food And Drug Administration Fda
Standard Operating Procedure Sop
u.s. Food and Drug Administration
Standard Operating Procedure
Michelle Jump Summary
Michelle Jump, based in United States, is currently a Chief Executive Officer at MedSec. Michelle Jump brings experience from previous roles at ISO - International Organization for Standardization and MedSec. Michelle Jump holds a 2008 - 2011 MS in Regulatory Science @ University of Southern California. With a robust skill set that includes 21 CFR Part 11, 510 K, Assurance Cases, Biotechnology, CAPA and more. Michelle Jump has 2 emails and 1 mobile phone numbers on RocketReach.
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