Teams at JenaValve Technology

Independently manages high-volume clinical safety activities across multiple medical device trials. Assesses adverse events and complaints, oversees reporting timelines and MedDRA coding, analyzes safety signals, prepares regulatory submission materials, and supports CEC and DSMB activities. Develops safety documentation, dashboards, presentations, and protocol content while collaborating with study sites, monitors, data management, and regulatory teams. Provides clinical safety expertise, responds to regulatory inquiries, mentors team members, and drives process improvements.

Serves as a trusted HR advisor to leaders and employees, primarily supporting manufacturing and production teams. Responsibilities include employee relations, investigations, performance management, workforce planning, talent development, recruiting support, onboarding, engagement, compliance, HR operations, and organizational effectiveness. Uses HR metrics to identify trends and improve retention and employee experience while partnering cross-functionally in a regulated medical device environment.

Leads site production operations for delivery systems, catheters, valves, and manufacturing/process engineering. Owns output, yield, throughput, cost, capacity planning, quality, safety, workforce readiness, KPI reporting, and production ramp activities. Partners with Quality, Regulatory, Supply Chain, HR, Facilities, and R&D to maintain compliant operations, drive process improvements, support audit readiness, and translate corporate strategy into production execution.