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Kate Mains, RAC

Director Global Regulatory Strategy
Bayer

Kate Mains, Director of Radiology Regulatory Strategy for Medical Devices at Bayer, is responsible for the PET infusion system and software AI/ML devices. Prior to joining Bayer, she held regulatory roles where she developed regulatory strategies and authored submissions for various devices including a wearable electromechanical software driven device, standalone software, including AI/ML devices, and implantable sterile devices. With over 15 years of experience, Kate’s expertise includes health authority consultations, technical file development, risk management, post-market surveillance, clinical trial applications, clinical evaluations, global registrations, and audits. Kate obtained a Bachelor of Science in Bioengineering from the University of Pittsburgh Swanson School of Engineering and holds Regulatory Affairs Certifications (RAC) through RAPS.

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