Dallas L. Thomas
Regulatory Affairs
LEADERSHIP TEAM
Global Regulatory Partners
Taiwan
Biography
Dallas L. Thomas has 6 years of experience in regulatory affairs, clinical development, quality management systems, compliance, and auditing. During his career, Dallas has worked on many 510(k) submissions for multiple medical devices and managed different compliance activities to ISO standards, FDA, and European regulations among other international market authorizations of products. As a Certified Lead Auditor for ISO 13485 issued by BSI, and a Six Sigma Yellow Belt, Dallas performed multiple QMS and ISO 13485 audits for medical devices. He has experience working with multi-disciplinary teams supporting product development. Additionally, he has exposure working with national & international regulatory standards such as new EU Medical Device Regulation (MDR), EU TPD 2014/40 EU, Good Manufacturing Practices (GMPs), ISO 13485, ISO 9001, Quality Systems Regulation (QSR), 21 CFR part 820, Food Drug and Cosmetics Act, RDC 185 (ANVISA in Brazil), MDD 93/42/EEC, and Latin America regulations among others.
Research Interest
Medical Device Regulation , Good Manufacturing Practices
