Katelyn Lesk

About Katelyn Lesk

Bioengineer and health coach. Lover of nature, Pittsburgh, and positive energy! Often…

Experience

1. Strategic Business & Regulatory Affairs Manager

   Nilo Medical Consulting Group

   Jan 2020 — Present

   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 Nilo Medical Consulting Group (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.

Education

• University of Pittsburgh

  Bioengineering

  2003 — 2007

Skills

• Statistics
• Bioengineering
• R&D
• Biotechnology
• Stem Cells
• Research and Development (R&D)
• Biomaterials
• Biomedical Engineering
• Regenerative Medicine
• Protein Chemistry
• Medical Devices
• Fda
• Mathematical Modeling
• Tissue Engineering
• Biomechanics
• Public Speaking