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Dallas Thomas
Sr. Regulatory & Quality Consultant
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An experienced consultant in regulatory affairs, quality compliance, auditing, remediation and clinical evaluation. During his career, Dallas has worked on 510(k) submissions for multiple medical devices and managed different compliance activities to ISO standards, MDSAP, FDA, and European regulations as well Clinical Evaluation Reports per MEDDEV 2.7/1 Rev 4 for EU compliance. Dallas has audited and defended audits of multiple manufacturers, and responded to FDA 483 letters.

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Experience

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  • Clinical Evaluation Reports (CER) SME - Bausch + Lomb Inc. via C2C Thomas Regulatory Resolutions, Inc .  

  • Regulatory Affairs & Auditing Consultant & CER Writer - LEAN RA/QA Systems via C2C Thomas Regulatory Resolutions, Inc .

  • Regulatory Affairs & Clinical Evaluation Consultant with Class III Cardiovascular Stent Manufacturer - Terumo Aortic.

  • RA and Clinical Evaluation Consultant - Ferrer Consulting Group via C2C Thomas Regulatory Resolutions, Inc.

  • Senior Regulatory Affairs and Compliance Manager and Auditor Consultant - Global Regulatory Partners via C2C Thomas Regulatory Resolutions, Inc .

  • Quality and Regulatory Consultant - US Ophthalmic via C2C Thomas Regulatory Resolutions, Inc.

  • Quality and Regulatory Consultant - Oxford International.

  • Senior Regulatory Affairs Specialist and Audit Team Member  - Zimmer Biomet.

  • International Regulatory Affairs Specialist - C.R. Bard, Inc., Bard Access Systems Division

 

Education

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  • Master of Health Administration (Emphasis in device regulatory affairs) - University of Utah-Salt Lake City

  • Bachelor of Science in Human Development - Brigham Young University

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Continuing Education

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  • RAC, EU Scope, Regulatory Affairs Certification issued by RAPS

  • Lead Auditor Certification (ISO 13485:2016) issued by BSI

  • Internal Auditor Certification (ISO 13485:2016) issued by BSI

  • Six Sigma Yellow Belt Certificate issued by Zimmer Biomet

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