Teams at ICU Medical

Provides global and US regulatory support for electromechanical medical devices. Prepares and maintains registration dossiers, evaluates manufacturing and labeling changes, interprets regulations, supports agency interactions, and develops regulatory strategies under oversight. Reviews technical documentation, resolves submission deficiencies, tracks registration activities, and advises product development and commercial teams. Leads regulatory discussions, presents scientific data, and coordinates with regional and country regulatory counterparts to ensure compliance and timely submissions.

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.

Manage and optimize a multi-account AWS environment supporting production healthcare applications and analytics platforms. Responsibilities include AWS infrastructure administration, CI/CD and infrastructure automation, observability, incident response, on-call support, disaster recovery validation, HIPAA/HiTrust compliance, IAM and security controls, and support for containerized Java and Python applications. The role also contributes to Kubernetes and EKS modernization initiatives and partners with developers to resolve complex production issues.