Head Global Regulatory Strategy, Device New Product Development @ (May 2017 - May 2019)
Regulatory Affairs Manager and Sr. Principal Regulatory Affairs Specialist @ (November 2014 - May 2017)
Principal Regulatory Affairs Specialist @ (April 2011 - November 2014)
Senior Regulatory Affairs Specialist @ (April 2006 - April 2011)
Regulatory Affairs Specialist @ (January 2005 - April 2006)
Regulatory Affairs and Quality Assurance Specialist @ (November 2002 - December 2004)
Design Engineer @ (February 2002 - November 2002)
Electrical Production Engineer @ (August 2000 - August 2001)
Electrical Engineering Co-Op @ (May 1998 - November 1999)
Lisa Ewing Education
University of Pittsburgh
Bachelor of Science - BS (Electrical Engineering)
1996-2000
Lisa Ewing Skills
Design Control
Clinical Trials
CE marking
Regulatory Documentation
Regulatory Submissions
510(k)
Clinical Evaluation Reports
Medical Devices
Regulatory Strategy Development
Change Control
Regulatory Requirements
Validation
21 CFR Part 11
Regulatory Affairs
V
FDA
Public Speaking
Marketing
Electrical Engineering
V&V
510k
Graphic Design
Engineering
ISO 13485
Product Launch
u.s. Food and Drug Administration Fda
u.s. Food and Drug Administration
Lisa Ewing Summary
Lisa Ewing, based in Pittsburgh, PA, US, is currently a Vice President, Global Regulatory Affairs - Orthopaedics and Robotics at Smith+Nephew. Lisa Ewing brings experience from previous roles at Smith+Nephew and Bayer. Lisa Ewing holds a 1996 - 2000 Bachelor of Science - BS in Electrical Engineering @ University of Pittsburgh. With a robust skill set that includes Design Control, Clinical Trials, CE marking, Regulatory Documentation, Regulatory Submissions and more. Lisa Ewing has 2 emails and 2 mobile phone numbers on RocketReach.
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