Teams at EBR Systems, Inc.

Leads regulatory strategy and submissions for Class III medical devices across US and international markets. Evaluates product and manufacturing changes, reviews technical, labeling, risk, promotional, and quality documents, supports audits, engages regulatory bodies, maintains compliance knowledge, and improves regulatory processes. The role requires cross-functional collaboration, project timeline management, and regulatory guidance for new and existing cardiac device products.

Provide clinical and technical subject-matter expertise for post-market surveillance and complaint investigations of implantable cardiac devices. Assess device performance, determine regulatory reportability, support root cause analysis, identify safety signals, ensure compliance with global regulations, and drive continuous improvement in complaint handling and PMS processes.