Ken Skodacek
Center for Devices and Radiological Health @FDA
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WORK HISTORY
Center for Devices and Radiological Health @FDA
Lead the development and implementation of policies, programs, and procedures intended to improve the quality, efficiency, and consistency of the Investigational Device Exemption (IDE) submission and review process. Work directly with FDA review teams and IDE sponsors in order to optimize interactions and communications during the review process in order to expedite initiation of clinical trials that fulfill regulatory requirements and collect valuable clinical evidence, ultimately improving patient access to high-quality, safe, and effective medical devices of public health importance. Coach, Facilitator, and Champion for Office of Personnel Management\'s Innovation Lab and Health and Human Services\' IDEA Lab and Ignite Accelerator
EDUCATION
University of Minnesota
Graduate Program, Biomedical Engineering
University of Illinois Urbana-Champaign
Bachelor of Science, Electrical Engineering
Parkland College
EMT, Emergency Medical Technician
SKILLS
ABOUT KEN SKODACEK
As a medical device professional, I am an enthusiastic results-driven team leader with over 30 years of experience working with implantable medical devices including the regulation of medical devices at FDA and numerous positions in the medical device industry including senior management, clinical studies, field-based operations, project management, marketing, and engineering.As a professional coach, I partner with people in a thought-provoking and creative process that inspires others to maximize their personal and professional potential. I create awareness, develop structures, and encourage actions in alignment with their goals. I tell them what they don\'t want to hear and have them see what they don\'t want to see in order to allow them to achieve goals, which they previously thought were impossible. I apply my coaching training and experience to all of my interactions in whatever role I\'m serving.
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