2016 -2020 Director, New Product Regulatory Affairs @
2011 -2016 Director, New Product Regulatory Affairs @
2005 -2011 Regulatory Affairs Manager - New Product Development @
2000 -2005 Concepts Engineer @
1996 -2000 Manager, Value Engineering and Technical Services @
1994 -1996 Cost Savings Engineer @
Jen Allen Education
Northwestern University
MS (Quality Assurance/Regulatory Science)
2007-2010
University of Illinois Urbana-Champaign
BS (Ceramic Engineering/ Polymer Science)
1989-1993
Jen Allen Skills
Medical Devices
FDA
OTC Drugs
Rx Drugs
Food & Drug Law
New Product Development
Product Engineering
Product Development
ISO 13485
CAPA
Invention
Regulatory Affairs
Design Control
21 CFR
FDA GMP
Pharmaceutical Industry
GMP
V&V
Quality Assurance
Change Control
Quality System
Regulatory Submissions
ISO 14971
Validation
21 CFR Part 11
R&D
GLP
Quality Auditing
LIMS
CE marking
U.S. Food and Drug Administration (FDA)
Food And Drug Law
JavaScript
U.S. Food And Drug Administration Fda
SQL
Management
u.s. Food and Drug Administration
Jen Allen Summary
Jen Allen, based in Cary, IL, US, is currently a Director, R and D Formulations at Stryker Sage. Jen Allen brings experience from previous roles at Stryker Sage and Sage Products LLC. Jen Allen holds a 2007 - 2010 MS in Quality Assurance/Regulatory Science @ Northwestern University. With a robust skill set that includes Medical Devices, FDA, OTC Drugs, Rx Drugs, Food & Drug Law and more. Jen Allen has 1 emails and 3 mobile phone numbers on RocketReach.
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