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Steve Mounts

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Steve Mounts

Vice President Regulatory Affairs and Quality Assurance | Paragon 28

Denver, Colorado, United States

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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.

General

Specialist

Technical Background

Leadership Experience

Long-Term Tenure

Professional interests

Industry-specific interests

Emerging Technologies

Leadership Development

Organisational experience

Startup Experience

Corporate Experience

Steve Mounts

Work Experience

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Vice President Regulatory Affairs and Quality Assurance at

Paragon 28

December 2023 - Present

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President | Founder at

MedDev Compliance

January 2016 - Present

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Vice President, Compliance, Regulatory Affairs and Quality at

Corelinksim Surgical

November 2016 - September 2023

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Vice President of Regulatory Affairs and Quality at

VENAXIS INC

July 2014 - December 2015

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Director of Quality Assurance & Regulatory Affairs / Compliance Officer at

Swan Valley Medical, Incorporated

October 2012 - July 2014

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Sr. Director / Consultant at

MCRA, an IQVIA business

May 2010 - October 2012

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Director Quality Systems and Regulatory Affairs at

McKesson

January 2010 - January 2010

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Director, Quality Systems at

Medtronic

January 2008 - January 2010

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Head of Quality Assurance at

DePuy Synthes

January 2004 - January 2008

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Manager, Corporate S/W Compliance at

DePuy Synthes

January 2000 - January 2004

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Sr. Quality Assurance Engineer & Regulatory Affairs Specialist at

Siemens Healthineers

January 1995 - January 2000

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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

mail

*******@paragon28.com

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