Jobs at JenaValve Technology

Design, develop, test, and document components and subsystems for transcatheter heart valves and delivery systems. Support procurement, assembly procedures, design verification, risk analysis, and transfer to manufacturing. Supervise technicians and collaborate with Quality and Manufacturing.

Lead and build an in-house clinical data management function: manage a team, own end-to-end data cleaning and query processes, partner with Clinical Operations, CROs, and Biostatistics, ensure CDISC-compliant datasets, support audits and regulatory submissions, and oversee EDC systems and SOPs.

Lead and manage the clinical compliance program for active clinical studies including risk-based audit programs, vendor qualification and oversight, CAPA management, SOP lifecycle and document control, regulatory intelligence (GCP/FDA/ICH/ISO), internal training, and direct supervision of a Clinical Compliance Specialist. Partner closely with Quality to ensure alignment and inspection readiness.

Supports Clinical Research Associates with site start-up, maintenance, and close-out activities; creates and maintains regulatory and subject binders; performs quality control of study documents for GDP and regulatory compliance; manages study supplies; prepares documentation, reports, and presentations; coordinates meetings and distributes minutes; provides on-site visit support and other incidental duties.

Lead second-shift THV production teams across tissue processing, valve assembly, solutions mixing, and tool cleaning. Manage planning, staffing, training, quality, KPIs, inventory, GMP compliance, troubleshooting, continuous improvement, and cross-functional coordination to support new product commercialization.

Lead and advance product safety risk management across the medical device portfolio, ensuring ISO 14971‑aligned practices from concept through post‑market. Develop policies, tools, and governance; support cross‑functional risk decisions; oversee risk management files, post‑market safety activities, regulatory submissions, audits, and metrics to ensure inspection readiness and patient safety.

Lead global product and innovation strategy and clinical education for TAVR for AR. Develop integrated training curricula, translate clinical insights into product and indication strategies, oversee cross-functional alignment, monitor outcomes/usability, and ensure compliance of strategic marketing and regulatory documentation.

Support conduct of pre- and post-market clinical studies: manage site interactions, data review and queries, maintain trial master files and regulatory documents, assist audits and monitoring, and support vendor management and process improvements.

Support conduct of pre- and post-market clinical studies by managing site interactions, data review and query resolution, maintaining trial master files, managing regulatory documents, supporting audits/inspections, and assisting monitoring and vendor qualification activities to ensure GCP and regulatory compliance.

Support site management and data activities for pre-market clinical studies, ensure GCP and regulatory compliance, maintain TMFs, provide EDC training, generate queries and reports, assist monitors, support audits and vendor management, and contribute to process improvements.

Lead supply chain planning and S&OP for an assigned portfolio, align demand and supply across functions and sites, manage inventory and ERP data, analyze forecast accuracy and KPIs, and execute risk mitigation to support production and business objectives.

Lead case planning and execution for global clinical trials, coordinate CRB meetings, manage imaging and screening workflows, develop SOPs and charters, mentor junior staff, and liaise with sites, core labs, and cross-functional teams to ensure timely subject enrollment and trial readiness.

Manage and maintain document/change control and training systems for a regulated medical device environment. Process and release controlled documents, verify closure of change orders, maintain records (DHF, DHR, test reports), create/maintain ERP items/BOMs/routings, support audits/inspections, train internal users, archive records, and ensure compliance with GDP and quality system requirements (21 CFR 820, ISO 13485).

Support clinical compliance operations including audit logistics, TMF/eTMF management, CAPA and non-conformance tracking, vendor qualification, SOP and training administration, and compliance metrics reporting to ensure inspection readiness and alignment with Quality.

Manage supplier quality for medical device components and materials: qualify suppliers, perform audits, negotiate and maintain supplier quality agreements, investigate nonconformances, support CAPA and complaint-related supplier actions, monitor supplier performance and drive continuous improvement while ensuring regulatory compliance (ISO 13485, 21 CFR 820, EU MDR, ISO 14971).

Lead a team of Site Managers while overseeing site management across clinical trials to ensure GCP and regulatory compliance, data integrity, TMF inspection readiness, CRO/vendor performance, site activation and enrollment, and cross-functional coordination. Split role between people management and hands-on study/site oversight; travel up to 25%.

Support clinical trial safety by assessing and reporting adverse events, performing MedDRA coding support, preparing narratives and safety reports, monitoring AE/SAE timeliness, collaborating with cross-functional teams, and contributing to protocol safety sections and DSMB/CEC activities.

Provide quality engineering support for transcatheter heart valve manufacturing including process characterization/validation (IQ/OQ/PQ), inspection and DHR review, test protocol/report creation, nonconformance investigations, root cause analysis, CAPA implementation, audit support, and cross-functional process improvements.