Senior Specialist, Regulatory Affairs

Develop and lead regional regulatory strategies for new and sustaining resuscitation products and features, ensuring successful device approvals. Serve as a strategic regulatory partner across development, review, and commercialization by authoring and preparing key submissions (e.g., IDEs, 510(k), PMAs) and aligning requirements across RA regional and product teams. Support risk assessment, audits, and cross-functional NPI project teams, maintaining current regulatory knowledge and driving continuous improvement.