This individual provides technical leadership and mentorship across Regulatory Affairs, drives regulatory excellence and continuous improvement, and leverages approved digital, automation, and generative AI tools to improve the quality, consistency, efficiency, and predictability of regulatory deliverables while maintaining appropriate human oversight and accountability for the final work product. The individual serves as a primary BMT representative in interactions with U.S. and international regulatory authorities and Notified Bodies, including independently developing FDA Pre-Submission strategies and meeting packages, leading regulatory authority meetings, presenting and defending BMT positions, and driving responses and follow-up actions.