Senior Manager, Clinical Compliance

🔥 1 hour ago

🏄 California – Remote

🏄 California – Remote

💵 $160k - $170k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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JenaValve Technology, Inc.

WebsiteLinkedInAll Job Openings

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

• Develop and execute a risk-based audit program covering internal processes and investigational sites; author audit plans and reports, and lead inspection readiness activities including TMF health assessments and mock inspections; partner with Quality on audit scheduling, joint audit conduct, and preparation for regulatory agency inspections (FDA, EU Notified Body) and corporate quality audits. • Own CAPA and non-conformance management for the department; serve as the central accountability point for CAPA status, effectiveness checks, and closure, coordinating with functional owners across sub-teams; maintain alignment with Quality on CAPA creation, classification, and tracking to ensure consistency with enterprise quality system requirements. • Own the vendor qualification and ongoing quality oversight program for CROs, core labs, EDC vendors, and other clinical service providers; issue and track SCARs, evaluate corrective action responses, and escalate unresolved quality issues with contract implications to leadership. • Lead the Clinical Affairs procedure lifecycle, including authoring, reviewing, and approving SOPs and work instructions; coordinate the annual review cycle across sub-departments; maintain the controlled document management system in alignment with enterprise quality system standards, serving as the primary liaison to Quality on document control processes and procedure governance. • Monitor and communicate regulatory developments and GCP guidance updates (FDA, ICH, EU CTR); evaluate impact on operations and procedures and serve as the department’s internal GCP compliance subject matter expert. • Design and deliver the Clinical Affairs internal training program, including GCP onboarding, procedural updates, and audit corrective action training; maintain training matrices and completion records for all department personnel. • Directly manage and develop the Specialist, Clinical Compliance; provide day-to-day direction, performance feedback, and professional development support. • Support continuous process improvement and PMA/IDE activities as they relate to compliance, study conduct quality, and regulatory commitments; complete training for internal SOPs and maintain current regulatory knowledge.

🎯 Requirements

• 7+ years in clinical research, clinical operations, or clinical quality assurance; medical device experience strongly preferred. • Minimum 3 years dedicated GCP audit or clinical compliance experience; demonstrated experience as a lead auditor conducting both site and vendor/CRO audits required. • Bachelor’s degree or higher in life sciences, health sciences, or a related field required; advanced degree preferred. • Thorough knowledge of ICH E6(R3), FDA regulations (21 CFR Parts 11, 50, 54, 56, 812), and ISO 14155; demonstrated SOP authorship and procedure lifecycle management experience. • Prior people management experience; ability to lead and develop direct reports in a fast-paced, growing organization. • Cardiovascular or structural heart therapeutic area experience is a significant advantage.