Overview Join Waters Advanced Diagnostics and help shape the future of clinical diagnostics. As Project Manager, Clinical Software, 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 (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) certification. Agile PM or equivalent type qualification preferable.
- 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.
- Understanding of the IVD product life-cycle n particular how thois relates to software.
- Computer literate - knowledge of Word, PowerPoint and Excel an advantage - in order to produce reports, analyse data etc effectively.
- Experince of managing software developmnet [rject in the life science industry.
- 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.
Vacancy posted 11 hours ago
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