Teams at ICU Medical

Supports global and US medical device registrations by creating and maintaining registration dossiers, advising product teams, preparing agency meeting materials, evaluating regulatory impact of changes, and ensuring regulatory compliance of submissions. Serves as a regulatory liaison, contributes to strategy, and tracks deliverables to meet deadlines.

Lead design quality activities for medical devices: apply quality tools, ensure FDA and international regulatory compliance, manage design controls, risk management, V&V, CAPA, investigations, audits, and cross-functional product change coordination. Monitor product data for trends, support 510(k) and technical files, and drive closure of quality issues.

Perform final quality reviews of production and sterilization records, manage nonconforming product holds, release conforming finished goods through Oracle, maintain DHR and outsourced sterilization documentation, generate sterility and Certificate of Conformance letters, and ensure compliance with ISO 13485 and FDA requirements.