Project Manager - Clinical Systems

Overview

Join Waters Advanced Diagnostics and help shape the future of clinical LCMS diagnostics. As a Project Manager you will lead the coordination of complex IVD development programmes, bringing together diverse teams to deliver innovative LC-MS diagnostic solutions that meet the highest standards of quality, regulatory compliance, and commercial success. This is an exciting opportunity to contribute to products that have a meaningful impact on patient care while developing your project management expertise within a fast-paced, highly collaborative environment.

Responsibilities

Project Leadership

• Support the end-to-end IVD product development project workstreams (assays, instruments, software)
• Assist cross-functional teams to define and project scope, timelines, milestones, and deliverables
• Work with the program and principal project managers to ensure workstreams are linked to the overall program goals.
• Develop and maintain integrated project plans and risk link up with risk management approach.
• Manage project execution to meet cost, schedule, and performance targets

• Collaborate with R&D, Clinical, Regulatory Affairs, Quality, Supply Chain, and Marketing
• Coordinate meetings, actions, and follow-ups across project teams
• Support clear communication of project updates and status

• Ensure projects comply with global regulatory requirements (IVDR, FDA 510(k), CE marking)
• Support design control processes (Design History File, risk management, validation)
• Partner with regulatory teams for submissions and approvals

• Identify and track project risks, issues, and dependencies
• Support development and monitoring of mitigation actions
• Escalate risks to senior project or programme managers as needed

• Support the management of project budgets, forecasting, and resource allocation
• Track and optimize project costs
• Ensure efficient utilization of team resources

• Support the management of external partners, CROs, and suppliers
• Support the management of contracts, deliverables, and performance

• Follow established project management processes and tools
• Contribute to improvements in PM practices and tools
• Demonstrate willingness to learn and develop PM capability

• Bachelor's degree in Life Sciences, Engineering, or related field
• Project Management Professional (PMP) training or certification. Agile PM or equivalent type qualification preferable

• 2-3 years of project management experience in IVD or life science related industry
• Willingness to learn and develop in a complex regulated environment.
• Experience of project management tools and methodologies (waterfall, agile, MS project, Smartsheet's)
• Good attention to detail.
• Basic understanding of an IVD product development lifecycle

• Self-starting, growth mindset with the ability work independently and as part of a team.
• Good written and oral communication skills are required, for example to ensure succinct report generation, effective communication with staff, peer groups, etc across organisation.
• Basis understanding of the IVD product life-cycle.
• Computer literate - knowledge of Word, PowerPoint and Excel an advantage in order to produce reports, analyse data etc effectively.

• 20% to Waters offices.