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Sue Hibbeln has more than 15 years in Regulatory Affairs and Quality Assurance at start-up, mid- and large-sized companies for a variety of medical devices, including in vitro diagnostic devices, software, hardware, implants and sutures. She currently serves as the company’s Senior Director of Regulatory Affairs. Ms. Hibbeln specializes in global strategy, registration, regulatory/cultural intelligence and quality systems.

Her passion for working with diverse cultures has enabled opportunities to work with world-class talent on global cross-functional teams. Ms. Hibbeln especially enjoys helping clients with global remediation and harmonization efforts and monitors direction from the International Medical Device Regulators Forum (IMDRF). Ms. Hibbeln is a CMMI Associate and a certified appraisal team member (ATM) for the Medical Device Discovery Appraisal Program (MDDAP) – a joint initiative for FDA, MDIC, and CMMI.

Ms. Hibbeln earned a BA from LaSalle University, an MS in Regulatory Affairs from San Diego State University and a Regulatory Affairs Certification (RAC) through the Regulatory Affairs Professionals Society (RAPS). She also completed the Kellogg Executive Leadership Program at Northwestern University.