Susan Hibbeln, Ms, Rac
About Susan Hibbeln, Ms, Rac
Susan Hibbeln is the Senior Director of Regulatory Affairs at Lumos Diagnostics, where she has worked since 2020. She has extensive experience in regulatory affairs, having held previous positions at Calypso Medical and CP Medical, and holds multiple certifications in the field.
Work at Lumos Diagnostics
Susan Hibbeln has been serving as the Senior Director of Regulatory Affairs at Lumos Diagnostics since 2020. In this role, she oversees regulatory strategies and compliance initiatives within the organization. Her position is based in Sarasota, Florida, where she contributes to the development and implementation of regulatory frameworks that align with international standards.
Previous Experience in Regulatory Affairs
Prior to her current role, Susan Hibbeln worked at Calypso Medical as the RA/QS Manager from 2006 to 2011. She also held the position of RA/QA Manager at CP Medical from 2001 to 2006. Additionally, she served as the Principal Scientific Advisor at Network Partners for one year, from 2019 to 2020, in Warsaw, Indiana. Her extensive experience spans over two decades in regulatory affairs.
Education and Expertise
Susan Hibbeln holds a Bachelor's degree from LaSalle University and a Master of Science (M.S.) in Regulatory Affairs from San Diego State University-California State University. She is certified in Regulatory Affairs Certification (RAC), Medical Device Single Audit Program (MDSAP), and Medical Device Data Application Program (MDDAP ATM). Her educational background and certifications underscore her expertise in international regulatory strategy and cultural intelligence.
Leadership in Quality Systems
In her role as Senior Director of Regulatory Affairs, Susan Hibbeln serves as a lead auditor in quality systems. This responsibility involves ensuring compliance with regulatory requirements and maintaining high standards within the organization. Her leadership in this area contributes to the overall effectiveness of Lumos Diagnostics' regulatory practices.