Mike Spears

Mike Spears Email and Phone Number

Senior Vice President, Regulatory Affairs and Compliance @ Solventum
Mike Spears's Location
United States, United States
Mike Spears's Contact Details
About Mike Spears

During my 30 years in the quality assurance, regulatory and compliance space for major medical device companies, my leadership has focused on bringing innovative products to market, increasing customer satisfaction, ensuring regulatory compliance and on-time delivery while implementing continuous improvement to enhance shareholder value. As Senior Vice President, Regulatory Affairs and Quality Assurance for Solventum, I establish and deliver quality assurance, regulatory affairs, and compliance strategies, and define and oversee the global quality management system for worldwide facilities and healthcare-related operations. Prior to joining Solventum, I was Senior Vice President, Regulatory Affairs and Compliance, Insulet Corporation where I provided overall leadership, strategy and management for the development and execution of all worldwide regulatory and compliance issues for its product portfolio. I made an impact through Quality Assurance and Regulatory leadership positions at Medtronic, Covidien and Tyco Healthcare.

Mike Spears's Current Company Details
Solventum

Solventum

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Senior Vice President, Regulatory Affairs and Compliance
Mike Spears Work Experience Details
  • Solventum
    Senior Vice President, Regulatory Affairs And Quality Assurance
    Solventum Apr 2024 - Present
  • 3M
    Senior Vice President, Regulatory Affairs And Quality Assurance
    3M Jan 2024 - Apr 2024
    St Paul, Mn, Us
  • Insulet Corporation
    Senior Vice President, Regulatory Affairs And Compliance
    Insulet Corporation May 2019 - Mar 2023
    Acton, Massachusetts, Us
  • Insulet Corporation
    Vice President, Quality, Regulatory And Clinical Affairs
    Insulet Corporation Jul 2015 - May 2019
    Acton, Massachusetts, Us
  • Covidien
    Vp, Quality Assurance & Regulatory Affairs
    Covidien Oct 2011 - Jul 2015
    Fridley, Minnesota, Us
  • Covidien
    Vp Quality Assurance
    Covidien Mar 2006 - Oct 2011
    Fridley, Minnesota, Us
  • Covidien
    Vice President, Quality Assurance
    Covidien Apr 2003 - Oct 2011
    Fridley, Minnesota, Us
  • Covidien Respiratory And Monitoring Solutions
    Global Vp, Quality Assurance
    Covidien Respiratory And Monitoring Solutions Apr 2006 - Oct 2011

Mike Spears Skills

Iso 13485 Quality Assurance Medical Devices Fda Regulatory Affairs Design Control Capa Quality System Cross Functional Team Leadership V&v Six Sigma Validation Root Cause Analysis Iso 14971 Gmp Dmaic U.s. Food And Drug Administration 21 Cfr Part 11 R&d Corrective And Preventive Action Verification And Validation Leadership Research And Development

Mike Spears Education Details

  • University Of South Carolina Darla Moore School Of Business
    University Of South Carolina Darla Moore School Of Business
    Business
  • University Of Tennessee, Knoxville
    University Of Tennessee, Knoxville
    Ba

Frequently Asked Questions about Mike Spears

What company does Mike Spears work for?

Mike Spears works for Solventum

What is Mike Spears's role at the current company?

Mike Spears's current role is Senior Vice President, Regulatory Affairs and Compliance.

What is Mike Spears's email address?

Mike Spears's email address is mi****@****pod.com

What is Mike Spears's direct phone number?

Mike Spears's direct phone number is +197860*****

What schools did Mike Spears attend?

Mike Spears attended University Of South Carolina Darla Moore School Of Business, University Of Tennessee, Knoxville.

What skills is Mike Spears known for?

Mike Spears has skills like Iso 13485, Quality Assurance, Medical Devices, Fda, Regulatory Affairs, Design Control, Capa, Quality System, Cross Functional Team Leadership, V&v, Six Sigma, Validation.

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