Dedicated to helping your company
Dallas L. Thomas, RAC, MHA, MPA is VP and Principal Regulatory, Quality, and Compliance Consultant for TRR. He brings experience in the areas of regulatory affairs, quality management systems, compliance, and auditing. Dallas works on activities associated with maintaining regulatory approval, compliance to ISO standards, FDA, and European regulations among other international market authorizations of products. His qualifications include Regulatory Affairs Certification (RAC) issued by the Regulatory Affairs Professionals Society, Certified Lead Auditor for ISO 13485 issued by BSI, and Certified Six Sigma Yellow Belt. He also brings his education to our team with a Bachelor's in Human Development, Masters' of Healthcare Administration, and Masters of Public Administration with emphasis in Regulatory Affairs. He has experience working with multi-disciplinary teams supporting product development. Dallas also brings exposure to national & international regulatory standards such as the 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. Dallas also bring his multilingual skills to our team, as he is fluent in Portuguese and Spanish, and has lived abroad in Latin America. Dallas has successfully assisted a number of manufacturers in their progress towards first time ISO Certification (9001 and 13485). Reach out to us today to see how we can assist your company.
Qualifications and Certifications:
ISO 13485 Lead Auditor Certification
Regulatory Affairs Certification (RAC)
Dallas Thomas, RAC, MHA, MPA, Certified Lead ISO Auditor, Six Sigma Yellow Belt
VP and Prinicpal Consultant of TRR