Katelyn Lesk
strategic business & regulatory affairs manager
Katelyn Lesk is a biomedical engineer who serves as a regulatory specialist and project manager, blending technical writing expertise with strategic insight to support a diverse portfolio of medical device clients. She has extensive experience supporting FDA submissions, with a specialization in regulatory strategies, Q-Submissions, and IDEs. Katelyn is also well-versed in programs like the FDA’s Safer Technologies Program (STeP) and Breakthrough Devices Program, helping clients navigate expedited pathways to market. In addition to her client-facing work, Katelyn also leads business operations, ensuring smooth internal processes, efficient and effective project delivery, and strategic business growth.
Katelyn brings to NMCG a depth of experience shaped by diverse roles across the medical device and health sectors. She began her career with at a medical device start-up developing a total spine arthroplasty device, gaining experience in testing, protocol development, quality assurance, surgical instrument design, and surgeon training. In the private sector, Katelyn gained specialized skills with auditing and written documentation such as FDA reports, risk analyses, company procedures, quality assurance documents, marketing materials, and surgeon training manuals, that have been directly applicable to her work in the regulatory industry. She also understands first-hand the operational pressures that many small companies face, particularly the high importance of quick turnaround times and efficient use of available capital, and strives to bring these values to NMCG.
Her broad experience includes supporting small businesses and nonprofit organizations, launching an online health coaching business in 2012, and contributing to the growth of local ventures in Pittsburgh’s business and tech scenes. She also dedicates time to volunteer efforts, particularly with 412 Food Rescue and its international arm, Food Rescue Hero.
Katelyn splits her time between Pittsburgh, Pennsylvania, and Avon, Colorado, and brings her love for the outdoors—especially the mountains—into her daily life and work philosophy.
For more information, please see her LinkedIn profile.