Carrie M. Kuehn, MA, MPH, LPD, RAC

Med-tech Regulatory Lead


Novateur Advisor Since





Therapeutics, Devices, Drug & Device Combination, Regulatory

“We are passionate about taking complex, multi-disciplinary problems and finding a sensible, strategic solution that provides the best opportunity for success."

Carrie M. Kuehn, MA, MPH, LPD, RAC
Med-tech Regulatory Lead

Dr. Kuehn is a regulatory affairs professional who is passionate about attacking complex problems where medicine, public health, and law intersect. She has a diverse background and over 20 years of experience in epidemiology, medicine, FDA regulatory affairs and patient-focused policy. Dr. Kuehn's training and education give her a strong foundation in science, medicine, statistics, law, and policy. In practice, Dr. Kuehn has applied her skills and expertise to the conduct of observational research, the application of FDA regulatory affairs to the medical products industry, and the development of, and advocacy for, patient-focused regulatory policy.

Dr. Kuehn is valued for her ability to simplify complex, multidisciplinary problems into a cohesive strategy that leads to efficient regulatory solutions. She is an accomplished researcher with exceptional written communication skills, having published in the areas of public health, regulatory affairs, and patient engagement policy. Dr. Kuehn excels at written and verbal communications with regulatory authorities, and is an expert at navigating US FDA regulatory policy. As part-time faculty with the College of Professional Studies at Northeastern University’s Regulatory Affairs Graduate program, Dr. Kuehn has the privilege of preparing the next generation of patient-focused regulatory professionals.

Dr. Kuehn is available to provide regulatory affairs consulting, particularly to medical device, software as a medical device (SaMD), and in vitro diagnostics companies. Dr. Kuehn is also available to provide policy research and advocacy support, as well as patient engagement strategy development. Ad hoc, short-term, and long-term regulatory consulting arrangements are available.

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