Project lead

Position Overview

The 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 Responsibilities

• Serve 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.

Qualifications

• Degree 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 & Travel

Position can be based in Mannheim (Germany), Indianapolis (USA) or Rotkreuz (Switzerland). Primary location is Rotkreuz.

EEO Statement

Roche is an Equal Opportunity Employer.