Teams 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.