Ron Arkin leads Arkin Consulting Group with more than 25 years’ experience in regulatory affairs, quality assurance, sterilization and validation. He managed a 45,000 sq. ft. facility providing technical GMP and sterilization processes to medical device, pharmaceutical, food, cosmetic and packaging industries, and led 30 successful 510(k) and international submissions. He had RA/QA/QC, operations and customer service responsibilities in addition to sales and operating and capital budgets. He managed an Ethylene Oxide facility for the world’s largest EtO sterilization company and overseeing the first contract sterilizer in the Southeast US to operate with no FDA citation. He is also an educator, advising and teaching graduate-level regulatory affairs, college-level didactic and clinical medical courses. Ron has lectured at FDA-GMP workshops and conducts seminars on auditing, process validations, quality system regulations, and other issues related to medical devices and drugs. He earned a BA in Physiology and an MS in Biological Science from Southern Illinois University. Ron is a member of the American Society for Quality (ASQ) and the Regulatory Affairs Professional Society (RAPS), a Medical Device HACCP Instructor and is a trained ISO-9000 lead assessor.