Senior Regulatory Affairs Specialist @ (June 2018 - January 2020)
Compliance Manager @ (September 2016 - June 2018)
Regulatory Affairs Specialist @ (June 2014 - August 2016)
Michael Mach Education
St. Cloud State University
Master's degree (Regulatory Affairs and Services)
2012-2013
St. Cloud State University
Bachelor of Science - BS (Biomedical Sciences, General)
2000-2005
Michael Mach Skills
21 CFR
510(k)
510(k) submissions
Ad promo
Adobe Acrobat
CAPA
CE marking
Chemistry
Documentation
Life Sciences
Medical Device Regulation (MDR)
Medical Devices
Presentations
Preventive Actions
Problem Solving
Product Registration
Quality System
Regulatory Affairs
Regulatory Audits
Regulatory Filings
Regulatory Requirements
Regulatory Submissions
Strategic Thinking
Technical Documentation
U.S. Food and Drug Administration (FDA)
Written Communication
Michael Mach Summary
Michael Mach, based in Minneapolis, MN, US, is currently a Regulatory Professional at Hologic, Inc.. Michael Mach brings experience from previous roles at Innovia Medical, Medtronic, Zirc Dental Products and RTI Surgical®. Michael Mach holds a 2012 - 2013 Master's degree in Regulatory Affairs and Services @ St. Cloud State University. With a robust skill set that includes 21 CFR, 510(k), 510(k) submissions, Ad promo, Adobe Acrobat and more. Michael Mach has 2 emails and 1 mobile phone numbers on RocketReach.
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