Janie brings more than 20 years of experience across the biotech and engineering industries, with expertise in Medical Affairs, drug delivery, combination products, and medical device design. She has 11 years of experience supporting human factors programs and regulatory submission documentation, including planning, conducting, and reporting usability studies to help ensure the safe and effective use of medical products.

Her consulting experience includes managing global client deliverables and translating research and usability insights into actionable user labeling and device requirements while aligning development programs with FDA expectations and industry standards.

Janie also brings significant leadership experience, including eight years managing direct reports, leading cross-functional teams, driving business initiatives, and implementing process improvements that support innovation and operational efficiency.