Ariel Barrett

About Ariel Barrett

Dr. Ariel Barrett, Ph.D, is a regulatory affairs leader with deep expertise in medical device strategy, FDA submissions, and cardiovascular technologies. With prior experience as a Team Lead at the U.S. Food and Drug Administration and current industry leadership at Asahi Intecc USA, she brings a rare dual perspective—understanding both the regulator’s expectations and the sponsor’s strategic objectives.Ariel has extensive experience guiding 510(k) submissions, regulatory pathway development, pre-submission strategy, and complex technical justifications involving infusion catheters, aspiration systems, thrombectomy devices, and embolic delivery technologies. Her work spans ISO 10993 biocompatibility evaluations, mechanical performance testing, and risk-based regulatory testing. She is known for translating highly technical engineering and clinical data into clear, persuasive regulatory narratives that withstand scrutiny.With a background in biomedical engineering and a strong foundation in scientific rigor, Ariel approaches regulatory strategy with precision, foresight, and efficiency. She partners cross-functionally with R&D, clinical, quality, and executive teams to de-risk programs early, streamline timelines, and align development with global regulatory expectations.Ariel is passionate about helping organizations bring innovative, safe, and effective technologies to patients—while building regulatory strategies that are proactive.

Experience

1. Associate Director of Regulatory Affairs

   Asahi Intecc Usa, Inc

   Jul 2025 — Present

Education

• Syracuse University

  Doctor of Philosophy (Ph.D.), Bioengineering and Biomedical Engineering

  2012 — 2017

• University of Maryland

  Bachelor of Science (B.S.), Bioengineering and Biomedical Engineering

  2007 — 2011