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Kathryn Kukulka

Regulatory Affairs

Kathryn Kukulka

After successfully running a Class I recall campaign for a blood glucose test strip manufacturer, Kathryn joined Omnica in 1998. As Omnica’s Director of Regulatory Affairs, she has demonstrated her leadership and management skills while using her working knowledge of regulatory requirements, ISO and IEC standards, design controls, FDA Quality Systems Regulations, human factors engineering, safety testing, and project management.

Kathryn works closely with Omnica’s engineering teams and clients from feasibility through development, and facilitates design transfer to manufacturing. She ensures that development activities associated with the Code of Federal Regulations (21CFR) for design controls, design input/output, risk assessment, design reviews, and design transfer are clearly defined while producing outputs that contribute to design histories. She has also managed the successful implementation of Project Data Management (PDM) for local engineering control and creates systems and strategies that support design control requirements for clients who request such support during the course of their programs. She has also contributed to the preparation of premarket notifications [510(k)’s] and Premarket Applications (PMAs) for medical device clients.

Kathryn has a BS degree in Environmental Health from Quinnipiac University in Connecticut and certificates in Medical Product Development from UCI, and Recording Engineering from Goldenwest College.