Leading regulatory and quality departments. Transforming a machine learning powerhouse into a SaMD pioneer.

Supporting regulatory planning, clinical development, and QMS enhancement with a focus on early-stage medical device manufacturers and AI/ML developers.

Successive leadership roles including leading 70-person department supporting $2.3B business. Partnered with Group and BU (business unit) Presidents and other senior executives on establishing and executing long term strategic and annual operational plans, launching new products and supporting existing on-market products, and making critical compliance decisions.

Led International Regulatory, Regulatory Operations and U.S. Pre-market Regulatory teams to support $1.6B business worldwide. Promoted in 2005 from Regulatory Affairs Manager.