Experience interacting directly with FDA and other global regulatory authorities to advance Class III medical devices through clinical development, regulatory submission, approval, and commercialization across multiple jurisdictions, including familiarity with applicable FDA submission processes and global requirements such as EU MDR, is preferred. Working closely with R&D, Regulatory Affairs, Quality, Product Management, clinical investigators, and executive leadership, you will balance the urgency of near-term clinical milestones with the rigor required to support patient safety, regulatory compliance, and high-quality clinical evidence.