Director Regulatory Affairs, Minimally Invasive Surgical Instruments @ (January 2018 - November 2020)
Sr. Director, Regulatory Affairs @ (May 2015 - April 2017)
Sr. Director, Regulatory Affairs @ (November 2013 - May 2015)
Director, Regulatory Affairs @ (May 2010 - October 2013)
Director, QA and RA @ (January 2009 - April 2010)
Manager, QA and RA @ (February 2004 - December 2008)
QA Supervisor and Quality Engineer @ (March 2001 - February 2004)
R and D Engineer, Project Manager @ (October 1996 - February 2001)
Researcher, Orthopaedic @ Wellesley Hospital (January 1994 - December 1997)
Jennifer Rae Education
University of Georgia - Terry College of Business
Executive MBA (Business Administration and Management, General)
2011-2013
University of Guelph
Bachelor of Engineering (B.Eng.) (Biomedical/Medical Engineering)
1991-1996
Jennifer Rae Skills
21 CFR
510 K
Biocompatibility
CAPA
CE marking
CMDCAS
CMDR
Capital Equipment
Catheters
Certified Internal Auditor
Class III Medical Devices
Combination Products
Corrective and Preventive Action (CAPA)
DMAIC
Design Control
Design Validations
Disposables
FDA
FDA GMP
GMP
IEC 60601
ISO 13485
ISO 14971
MDL
Medical
Medical Device Directive
Medical Device Product Development
Medical Device Risk Analysis
Medical Devices
Post Market Surveillance
Product Launch
Project management
Quality Control
Quality System
Quality System Compliance
Regulatory Affairs
Regulatory Analysis
Regulatory Risk
Regulatory Strategy
Regulatory Submissions
Risk Analysis
Six Sigma
Strategy
Supplier Auditing
Technical Files
U.S. Food and Drug Administration (FDA)
US RAC Certification
V
quality engineering
regulatory compliance
Microsoft Office
u.s. Food and Drug Administration Fda
Management
Due Diligence
Regulatory
Data Analysis
Testing
Corrective and Preventive Action Capa
Compliance
Quality Assurance
u.s. Food and Drug Administration
Corrective and Preventive Action
Jennifer Rae Summary
Jennifer Rae, based in United States, is currently a Vice President, Regulatory Science and Communications at MiniMed. Jennifer Rae brings experience from previous roles at Medtronic. Jennifer Rae holds a 2011 - 2013 Executive MBA in Business Administration and Management, General @ University of Georgia - Terry College of Business. With a robust skill set that includes 21 CFR, 510 K, Biocompatibility, CAPA, CE marking and more. Jennifer Rae has 1 emails and 2 mobile phone numbers on RocketReach.
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