Katie O’Kelly

Katie is a seasoned quality and regulatory leader with nearly 15 years of experience in the medical device industry. Passionate about driving operational excellence and delivering high-quality, compliant products, she has been instrumental in helping organizations navigate complex regulatory landscapes while ensuring patient safety and product effectiveness.

With a deep expertise in FDA and international regulatory compliance, Katie has held key roles at industry-leading medtech companies. At Johnson & Johnson and W.L. Gore & Associates, she gained hands-on experience in manufacturing engineering, new product development, and all aspects of quality management. She then advanced into additional leadership roles at Terumo Medical Corporation, where she led global cross-functional teams in acquisition and co-development projects, overhauled quality system processes, and fostered a company-wide culture of quality.

As a quality and regulatory consultant at Biologics Consulting Group, Katie leveraged her extensive industry experience to guide companies through every aspect of quality management systems. She has led global FDA 483 and Warning Letter remediation efforts, designed tailor-made quality systems for all classes of medical devices, authored regulatory submissions, conducted international mock-FDA inspections, and led due diligence and integration activities for acquisitions.

Katie holds dual Bachelor of Science degrees in Bioengineering and International Studies from The Schreyer Honors College at The Pennsylvania State University. She is committed to helping organizations achieve regulatory and quality excellence through strategic leadership, continuous improvement, and dedication to meeting customer needs.