JenaValve Technology, Inc.
51 - 200 employees
Founded 2013
🏥 Healthcare
🔧 Hardware
🏭 Manufacturing
💰 $100M Series C - JenaValve Technology on 2022-08
Healthcare • Hardware • Manufacturing
JenaValve Technology, Inc. is a medical device company that developed the Trilogy Transcatheter Heart Valve System, the first and only FDA‑approved transcatheter aortic valve replacement (TAVR) specifically indicated to treat severe native tricuspid aortic valve regurgitation (AR). The Trilogy system uses locator technology to achieve commissural alignment and anchor the valve to native leaflets even when calcium is absent, and features a self‑expanding nitinol frame, porcine pericardial tissue with proprietary treatment, a purpose‑built delivery catheter, and an extended introducer sheath designed for stability and precise deployment. JenaValve markets the system for high‑risk surgical patients and supports its product with pivotal clinical study data demonstrating high technical success and low rates of embolization and residual AR.
Clinical Compliance Specialist
🔥 58 minutes ago
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JenaValve Technology, Inc.
51 - 200 employees
Founded 2013
🏥 Healthcare
🔧 Hardware
🏭 Manufacturing
💰 $100M Series C - JenaValve Technology on 2022-08
Healthcare • Hardware • Manufacturing
JenaValve Technology, Inc. is a medical device company that developed the Trilogy Transcatheter Heart Valve System, the first and only FDA‑approved transcatheter aortic valve replacement (TAVR) specifically indicated to treat severe native tricuspid aortic valve regurgitation (AR). The Trilogy system uses locator technology to achieve commissural alignment and anchor the valve to native leaflets even when calcium is absent, and features a self‑expanding nitinol frame, porcine pericardial tissue with proprietary treatment, a purpose‑built delivery catheter, and an extended introducer sheath designed for stability and precise deployment. JenaValve markets the system for high‑risk surgical patients and supports its product with pivotal clinical study data demonstrating high technical success and low rates of embolization and residual AR.
📋 Description
• Support audit planning and execution for internal and investigational site audits • Enter, track, and monitor CAPAs, non-conformances, and audit corrective actions • Support vendor qualification activities for CROs, core labs, and other clinical service providers • Maintain compliance metrics dashboards • Support continuous process improvement and other clinical affairs deliverables as needed
🎯 Requirements
• 2+ years in clinical research, clinical operations, or clinical quality assurance • Bachelor's degree or higher in life sciences, health sciences, or a related field required • Working knowledge of ICH E6 GCP guidelines and FDA regulations • Familiarity with ISO 14155 preferred • Strong organizational skills and attention to detail • Excellent written and verbal communication skills
🏖️ Benefits
• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Remote work options
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