Project lead

Position OverviewThe 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.Key ResponsibilitiesServe as central point of contact for U.S. market introduction of the CGM solution, overseeing cross‑functional collaboration across global functions.Lead, plan and execute the project ensuring delivery to timelines, budgets and specifications.Develop and maintain product development strategies from project initiation to market launch decisions.Coordinate planning, risk mitigation, and resource allocation with stakeholders in Finance, Project Management, Operations, and R&D.Develop and evaluate strategic options based on time, cost, risk, technical, regulatory, business, and operational requirements.Communicate risks and mitigation plans to senior stakeholders.Build and motivate multidisciplinary teams in a global matrix environment, manage change and resolve conflicts.Represent the team in external interactions, including U.S. FDA engagement and other stakeholders.QualificationsDegree in science, engineering or equivalent; MBA or PhD an advantage.At least 8 years of professional experience in project management and leadership, with 6+ years in diagnostics or pharma development/operations.Experience with MDR, IVDR and U.S. product approval projects (510(k) or equivalent).Demonstrated expertise in FDA regulatory processes, study planning, execution, and engagement with the U.S. FDA.Strong leadership skills in managing multidisciplinary teams within a global matrix organization.Excellent communication skills in English – verbal and written – and ability to present to large audiences.Willingness to travel ~25% of the time.Location & TravelPosition can be based in Mannheim (Germany), Indianapolis (USA) or Rotkreuz (Switzerland). Primary location is Rotkreuz.EEO StatementRoche is an Equal Opportunity Employer.
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