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Steve Mounts
Steve Mounts
Vice President Regulatory Affairs and Quality Assurance | Paragon 28
Denver, Colorado, United States
Steve Mounts
Summary
Steve Mounts is a seasoned Strategic Regulatory Affairs Leader with extensive experience in the medical device industry. He has a proven track record of driving compliance and quality assurance initiatives across various organizations, from startups to established corporations. Known for his innovative problem-solving skills, Steve excels in building high-performing interdisciplinary teams and implementing programs that enhance product yields while reducing costs. His expertise spans FDA regulatory compliance, quality system development, and risk management, making him a sought-after leader in the field. With a strong focus on cybersecurity in medical devices, he has published several articles addressing emerging risks and compliance strategies. Steve’s educational background in Industrial Technology and Geology further complements his diverse skill set.
Steve Mounts
Work Experience
Vice President Regulatory Affairs and Quality Assurance at
Paragon 28
December 2023 - Present
President | Founder at
MedDev Compliance
January 2016 - Present
Vice President, Compliance, Regulatory Affairs and Quality at
Corelinksim Surgical
November 2016 - September 2023
Vice President of Regulatory Affairs and Quality at
VENAXIS INC
July 2014 - December 2015
Director of Quality Assurance & Regulatory Affairs / Compliance Officer at
Swan Valley Medical, Incorporated
October 2012 - July 2014
Sr. Director / Consultant at
MCRA, an IQVIA business
May 2010 - October 2012
Director Quality Systems and Regulatory Affairs at
McKesson
January 2010 - January 2010
Director, Quality Systems at
Medtronic
January 2008 - January 2010
Head of Quality Assurance at
DePuy Synthes
January 2004 - January 2008
Manager, Corporate S/W Compliance at
DePuy Synthes
January 2000 - January 2004
Sr. Quality Assurance Engineer & Regulatory Affairs Specialist at
Siemens Healthineers
January 1995 - January 2000
Steve Mounts
Education
California State University-Fresno, Bs
Frequently Asked Questions about Steve Mounts
What is Steve Mounts email address?
Steve Mounts's primary email address is *******@paragon28.com. To view the full verified email and additional contact details, sign up for free with Muraena.
What company does Steve Mounts work for?
Steve Mounts is a Vice President Regulatory Affairs and Quality Assurance at Paragon 28, a company specializing in Medical Equipment & Supplies Manufacturing.
Where Steve Mounts graduated from?
Steve Mounts holds a degree in Industrial Technology/Manufacturing Automation from California State University-Fresno.
How can I directly contact Steve Mounts?
To contact Steve Mounts directly, you can use the email address *******@paragon28.com. Complete contact information is available upon registration with Muraena.
Who is Steve Mounts?
Steve Mounts is a seasoned Strategic Regulatory Affairs Leader with extensive experience in the medical device industry. He has a proven track record of driving compliance and quality assurance initiatives across various organizations, from startups to established corporations. Known for his innovative problem-solving skills, Steve excels in building high-performing interdisciplinary teams and implementing programs that enhance product yields while reducing costs. His expertise spans FDA regulatory compliance, quality system development, and risk management, making him a sought-after leader in the field. With a strong focus on cybersecurity in medical devices, he has published several articles addressing emerging risks and compliance strategies. Steve’s educational background in Industrial Technology and Geology further complements his diverse skill set.
Steve`s contact details
*******@paragon28.com
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