ph3Position Overview /h3pThe role is Global Project Lead in the Continuous Monitoring Lifecycle Team (LCT) focused on the U.S. FDA approval of a continuous glucose monitoring (CGM) solution. /ph3Key Responsibilities /h3ulliServe as central point of contact for U.S. market introduction of the CGM solution, overseeing cross‑functional collaboration across global functions. /liliLead, plan and execute the project ensuring delivery to timelines, budgets and specifications. /liliDevelop and maintain product development strategies from project initiation to market launch decisions. /liliCoordinate planning, risk mitigation, and resource allocation with stakeholders in Finance, Project Management, Operations, and RD. /liliDevelop and evaluate strategic options based on time, cost, risk, technical, regulatory, business, and operational requirements. /liliCommunicate risks and mitigation plans to senior stakeholders. /liliBuild and motivate multidisciplinary teams in a global matrix environment, manage change and resolve conflicts. /liliRepresent the team in external interactions, including U.S. FDA engagement and other stakeholders. /li /ulh3Qualifications /h3ulliDegree in science, engineering or equivalent; MBA or PhD an advantage. /liliAt least 8 years of professional experience in project management and leadership, with 6+ years in diagnostics or pharma development/operations. /liliExperience with MDR, IVDR and U.S. product approval projects (510(k) or equivalent). /liliDemonstrated expertise in FDA regulatory processes, study planning, execution, and engagement with the U.S. FDA. /liliStrong leadership skills in managing multidisciplinary teams within a global matrix organization. /liliExcellent communication skills in English – verbal and written – and ability to present to large audiences. /liliWillingness to travel ~25% of the time. /li /ulh3Location Travel /h3pPosition can be based in Mannheim (Germany), Indianapolis (USA) or Rotkreuz (Switzerland). Primary location is Rotkreuz. /ph3EEO Statement /h3pbRoche is an Equal Opportunity Employer. /b /p /p #J-18808-Ljbffr
