• Lead the execution of device clinical studies, ensuring compliance with applicable regulations and internal procedures. • Manage relationships with subject matter experts, key opinion leaders, and investigators to support high-quality clinical data and submissions. • Provide clinical input and oversight for regulatory strategy and submissions, including verification and validation activities. • Oversee CRO relationships to ensure delivery against timelines, quality, and regulatory requirements. • Ensure compliance of product labeling and promotional materials with regulatory requirements. • Facilitate cross-functional alignment to achieve clinical program objectives. • Address complex operational or protocol issues requiring senior clinical judgment. • Travel to scientific meetings and clinical sites as needed, both domestically and internationally.