Memphis Regulatory Consulting, LLC
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Kim Strohkirch, M.S.E.
 
Prior to consulting, Kim spent 3 years at Medtronic Spinal and Biologics working on design control activities, annual reports, PMA supplements, change control, and labeling related to cervical and lumbar arthoplasty devices. She also spent two years at Cook Med Institute developing clinical protocols and managing studies for peripheral bare metal and drug-eluting stents. Engineering principles were used to develop regulatory strategy and pre-clinical testing to obtain clearances and approvals.

Kim received a Bachelor of Science in Mechanical Engineering from The University of Memphis and a Masters of Science in Engineering from the department of Aeronautics and Astronautics from Purdue University. She has completed other graduate engineering courses at The University of Memphis with an emphasis in materials.

 
Christine Scifert, M.S., M.E.M.

Prior to consulting, Christine spent 9 years at Medtronic Spinal and Biologics directing the regulatory department of 22 people. As Senior Director of the group, she set regulatory strategy, oversaw global submissions, developed a design control process, interfaced with FDA and notified bodies, oversaw modification and implementation of procedures to maintain regulatory compliance and performed due diligence activities for potential acquisitions. Prior to Medtronic, she performed evaluations of injury mechanisms associated with automobile collisions, slip and falls, and sport/recreation accidents.

Christine received a Bachelor of Science in Physics from Hamline University and a Masters of Science in Biomedical Engineering from University of Iowa. She also completed a Masters in Engineering Management from Christian Brothers University.

Dawn Norman, M.S.

Before joining MRC in 2014, Dawn spent 15 years in the medical device industry working with venture capital backed start-ups and larger companies alike. She focused on regulatory strategy and submissions, along with clinical study design and study execution, for products such as, magnetic navigation devices for neurosurgical, neurovascular and cardiac indications, high intensity ultrasound for cardiac ablation, recombinant proteins for bone fusion, orthopedic trauma and imaging technologies.

Dawn received a Bachelor of Arts in Biological Sciences and Chemistry, and a Masters of Science in Biomedical Sciences from Southern Illinois University at Edwardsville.