Senior Director, Regulatory & Quality Counsel, Global will independently manage significant legal projects, advise leadership on complex regulatory risks, support interactions with FDA and global health authorities, lead legal support for regulatory inspections and enforcement actions, and provide strategic guidance on remediation programs, product development, commercialization, and global compliance initiatives. This role provides expert legal counsel on the full spectrum of medical device regulatory, quality, compliance, enforcement, and commercialization matters across the product lifecycle, including emerging technologies such as artificial intelligence (AI), software as a medical device (SaMD), digital health, and connected medical devices products.