MADISON, Wis.– Voximetry Incorporated, a Healthtech company with software designed to change the Standard of Care for late-stage prostate cancer patients by creating personalized treatment plans tailored for the individual, has announced the appointment of Jill Kaeder as Vice President of Regulatory Affairs and Quality Assurance.
Jill has worked in Medical Device regulated environments for over 25 years. She has managed RA/QA programs for software as a medical device (SaMD), imaging systems, general purpose reagents (GPRs), bulk pharmaceuticals and device accessories. Her considerable experience as a Quality & Regulatory Affairs leader includes leadership roles at Philips and Accuray.
According to Voximetry CEO, Dr. Sue Wallace, “Having worked with over 50% of our team in a previous role at Philips, Jill is a known entity to our team. She has a track record of fast turn-around times and successful regulatory approvals including a consistent track record of no major findings and lightning speed FDA approvals. Her arrival to Voximetry comes at the perfect time to mature our QMS to the next level and efficiently drive market clearance in global markets.”
Most important to a start-up environment, Jill excels in the creation and implementation of QMS systems. Her track record of evaluating a system’s impact cross-functionally, organizing and assessing data quality for submissions, and interpreting the needs of RA/QA to a software developer, a department head, or an implementation team is outstanding.
She has experience holding responsibility for compliance with US FDA QSRs, European MDD/MDR, MDSAP requirements, ISO 13485, and more. This includes interfacing with local and international regulatory bodies such as FDA, European competent authorities and notified bodies, as well as numerous international authorities including Health Canada, SFDA, KFDA, JPMD, and TGA.
Born in Escanaba, MI, Jill holds a degree from the University of Wisconsin – Green Bay and has maintained a Regulatory Affairs Certificate (RAC) since 2004.
She enjoys traveling with her family, reading, needle arts, and gardening.