Susan Rolih, RAC
Principal Regulatory Consultant
Susan Rolih, RAC, Principal Regulatory Consultant, Clinical Research Consultants, Inc., is an experienced quality assurance and regulatory affairs leader specializing in the in vitro diagnostics (IVD) and life science industries. Ms. Rolih has worked in the IVD sector for 40 years and has over 25 years of experience at the executive level of global diagnostics and life science companies. She has led multiple cross-functional teams to establish corporate quality and regulatory strategies. She has extensive experience in the application of the US Quality System Regulations and ISO 13485, and has assisted multiple clients remediate quality system deficiencies arising from FDA inspections or ISO audits. She is experienced in IVD product submissions to the US Food and Drug Administration [510(k), Pre-Submission, Pre-EUA, EUA, BLA], US Department of Agriculture (animal diagnostic licenses), European Union (IVD products for professional use and self- testing), and other global regulatory documents (including IVD submissions to Argentina, Australia, Brazil, Canada, Columbia, Japan, Singapore, Malaysia, Mexico, India, Pakistan, etc). Ms. Rolih received a Bachelor’s degree in Medical Technology from Arizona State University and a Master’s degree in Immunohematology from the University of Cincinnati.