Engaging With AI: A Discussion of AI-Related Legal Careers

BENJAMIN ZEGARELLI provides regulatory compliance counsel to global clients developing and marketing FDA-regulated products with the goal of mitigating compliance concerns and obstacles facing product candidates or commercialized products while helping clients achieve commercial success. With a clear focus on medical device compliance matters, Benjamin advises life science and health care industry clients, on the federal and state laws governing the design, production, quality, and commercialization of a variety of device types. In particular, he has counseled numerous software device, including software as a service (SaaS), developers, especially those designing software that incorporates artificial intelligence (AI) or machine learning (ML) functionalities, on FDA regulatory strategy, including preparing for pre-submission meetings with FDA, submitting applications for marketing authorization, and responding to agency requests for additional information. Benjamin also assists life sciences clients with medical product distribution, advertising, promotion, and labeling compliance, as well as negotiating contractual relationships with suppliers and other contractors.