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Melissa Young Location
Anoka, MN, US
Melissa Young Work
Regulatory Affairs Director @ (October 2019 - Present)
Senior Regulatory Affairs Manager @ (September 2016 - October 2019)
Principal Regulatory Affairs Specialist @ (November 2014 - September 2016)
Regulatory Affairs Manager @ (June 2013 - November 2014)
Senior Regulatory Affairs Specialist @ Medafor Inc. (March 2012 - May 2013)
Senior Regulatory Affairs Specialist @ (January 2005 - March 2012)
Melissa Young Education
St. Catherine University
Bachelor of Science (Marketing/Management, minor Economics)
2001-2005
Melissa Young Skills
ISO 13485
PMA
Design Control
FDA
Regulatory Affairs
ISO 14971
Medical Devices
Validation
CE marking
GMP
Regulatory Submissions
Quality System
CAPA
Biomedical Engineering
Medical Device Directive
V&V
21 CFR
Cross-functional Team Leadership
Regulatory Requirements
21 CFR Part 11
Corrective and Preventive Action (CAPA)
U.S. Food and Drug Administration (FDA)
Regulatory
Strategy
Cross Functional Team Leadership
Project Management
Public Relations
Research
Program Management
Corrective and Preventive Action Capa
u.s. Food and Drug Administration Fda
Management
Integration
Leadership
Marketing Communications
Proposal Writing
Editing
Health Insurance
Marketing
Corporate Communications
Product Launch
Strategic Planning
Integrated Marketing
Writing
Publications
Direct Marketing
Corrective and Preventive Action
u.s. Food and Drug Administration
Melissa Young Summary
Melissa Young, based in Anoka, MN, US, is currently a Regulatory Affairs Director at Boston Scientific. Melissa Young brings experience from previous roles at Boston Scientific, CR Bard/Davol and Medafor Inc.. Melissa Young holds a 2001 - 2005 Bachelor of Science in Marketing/Management, minor Economics @ St. Catherine University. With a robust skill set that includes ISO 13485, PMA, Design Control, FDA, Regulatory Affairs and more. Melissa Young has 3 emails and 6 mobile phone numbers on RocketReach.
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