Jobs at EBR Systems, Inc.

Senior Clinical Research Associate responsible for clinical monitoring, data integrity, and site engagement across device studies. Ensures compliant study conduct (ICH-GCP, 21 CFR 11, GDPR), supports enrollment and site performance, monitors/adjudicates adverse events, trains sites on EDC/eTMF/CTMS, collaborates with cross-functional teams, oversees CRO activities, and contributes to audit readiness and clinical reporting. Requires cardiovascular implantable device expertise.

Provide regulatory guidance for medical device projects, develop and execute global regulatory strategies, prepare and submit regulatory submissions, assess product and manufacturing changes, support audits, maintain regulatory compliance, and communicate requirements to cross-functional teams to ensure timely market authorization.

Lead design, implementation, and maintenance of automated measurement and inspection systems. Drive test method validation, MSA, SPC, root-cause investigations, CAPA/NCR closure, supplier quality, and documentation to ensure medical device regulatory compliance and improved yields. Mentor inspectors and support production troubleshooting.

Lead and execute scientific affairs and evidence-generation programs for Class III cardiovascular devices. Drive publication planning, KOL engagement, conference coverage, post-market studies, and cross-functional collaboration with R&D, Clinical, Regulatory, Commercial, and Market Access to translate clinical data into scientific communications and value narratives.

Support internal communications, employee engagement, and events. Draft and maintain internal content and channels (SharePoint), coordinate Town Halls, administer engagement surveys and recognition programs, support onboarding experience, and assist technology and cybersecurity communications. Collaborate with HR and People Ops to execute logistics and programming.

Lead quality engineering for medical device products, authoring and managing design verification/validation, software/firmware testing, risk analysis, CAPA and complaint investigations. Support production troubleshooting, collaborate with contract manufacturers, ensure regulatory compliance (FDA/EU), and maintain quality system documentation and standards.