Kory Dillman Email & Phone Number

Consult with clients in the medical device and digital health industries, providing regulatory direction and strategy in accordance with applicable regulations: FDA (pre-submission, 510K, De Novo, PMA), EU (MDR/IVDR), HealthCanada, BfArM (including DiGA).- Interpret regulatory requirements into practical, workable strategies that align with business objectives; assist in the authoring, review, comment adjudication, and finalization of submission-related documents.- Serve as a liaison… Show more Consult with clients in the medical device and digital health industries, providing regulatory direction and strategy in accordance with applicable regulations: FDA (pre-submission, 510K, De Novo, PMA), EU (MDR/IVDR), HealthCanada, BfArM (including DiGA).- Interpret regulatory requirements into practical, workable strategies that align with business objectives; assist in the authoring, review, comment adjudication, and finalization of submission-related documents.- Serve as a liaison between regulatory and other functional areas including external partners and consultants in planning, organizing, and preparing regulatory documents for submission. Show less

Kansas City, Missouri, United States

Kansas City, Missouri Area

Provide regulatory oversight and strategy for product design, development, and marketing for 6 different Software as a Medical Device (SaMD) products, spanning medical imaging, women’s health, and cardiology practices. - Ensure compliance with ISO standards (9001, 27001, 62304, 13485, 14971, etc.) and regional regulations and guidances (Regulation (EU) 2017/745, FDA, MEDDEV, TGA, etc). - Work across strategy, engineering, and Ux to develop product requirements and business cases… Show more Provide regulatory oversight and strategy for product design, development, and marketing for 6 different Software as a Medical Device (SaMD) products, spanning medical imaging, women’s health, and cardiology practices. - Ensure compliance with ISO standards (9001, 27001, 62304, 13485, 14971, etc.) and regional regulations and guidances (Regulation (EU) 2017/745, FDA, MEDDEV, TGA, etc). - Work across strategy, engineering, and Ux to develop product requirements and business cases through software release activities and post-market follow-up with the client base. Teams are based in the US and India. - Prepare regulatory reports and submissions for US and global markets, including 510(k), risk management reports, clinical evaluation, and technical files; participate in internal and external quality and certification audits. - Consult with PMO to refine processes to better align with product team workflows. - Graduate, Cerner RISE Leadership Development Program, February 2021 Show less

Kansas City, Missouri Area

Provide regulatory oversight and internal/external audit support for medical devices. Work directly with engineering teams to ensure development activities are in compliance with requirements of Cerner’s internal quality system, FDA, EU, and other global regulatory agencies.

Worked with CEO of marketing automation provider to realign business structure, develop a growth playbook, and implement operational strategies to provide continuous process improvement and growth.- Softvu acquired by New Capital Partners

Productized service and developed go-to-market strategy for DriverScore. Functional areas of management involved strategic planning, business development, marketing, sales, and product management. Operating improvements and launch strategy positioned start-up as an effective vendor to leading transportation brands, including DHL, Coca-Cola Enterprises, US Xpress, and Zurich. DriverScore was OEM option on select Ford vehicles.

Started company to provide Wi-Fi hot spots at locations convenient to highway travelers. Start-up strategy attracted over $10 million in venture capital and positioned company as industry-leading Wi-Fi provider with over 500 hot spots across the country. Responsible for providing strategic and day-to-day operations covering technology, product development, regulatory (public company), facilities, and business development.

Developed and managed public access kiosk system operating nationwide. Kiosk served as information portal offering trip routing, email access, and other services useful to highway travelers. Positioned service as an effective advertising medium for Fortune 500 companies to include Volvo Trucks, Ford Motor Company, Harley Davidson, and Caterpillar Engines.

Kansas City, Missouri Area

Boutique design shop providing digital marketing services, brand development, web site launch, and strategic consulting. Clients included Marriott Hotels, USDA, Sprint, American Airlines, and Dickenson Theaters. - PSI acquired by TIMM Communications in 1997