Project Manager, Regulatory Compliance Specialist, Project & Program Management

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 work streams (Software)
Assist cross-functional teams to define and project scope, timelines, milestones, and deliverables

Work with the program and principal project managers to ensure work streams 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

Cross-Functional Coordination 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

Regulatory & Compliance 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

Risk & Issue Management 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

Financial & Resource Management Support the management of project budgets, forecasting, and resource allocation

Track and optimize project costs

Ensure efficient utilization of team resources

Vendor & Partner Management Support the management of external partners, CROs, and suppliers

Support the management of contracts, deliverables, and performance

Continuous Improvement Follow established project management processes and tools

Contribute to improvements in PM practices and tools

Demonstrate willingness to learn and develop PM capability

Qualifications

Education:

Bachelor’s degree in Life Sciences, Engineering, or related field

Project Management Professional (PMP) certification. Agile PM or equivalent type qualification preferable.

Experience:

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.

Competencies:

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 a product development lifecycle. Travel (If Applicable):20% to Waters sites and colaborators. In addition to salary, we work flexibly and provide 25 days holidays, excellent family friendly benefits such as attractive employer pension contribution, life assurance, income protection and private medical. With Waters, there are plenty of opportunities for you to grow, develop and contribute.

Company Description Waters Corporation (NYSE:WAT) is a global leader in life sciences and diagnostics, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, our innovative portfolio harnesses deep scientific expertise across chemistry, physics, and biology. We collaborate with customers around the world to advance the release of effective, high-quality medicines, ensure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combating antibiotic resistance.

Through a shared culture of relentless…