Overview

Join our team as a Senior Project Manager and play a key role in delivering innovative IVD assay products from concept through to commercialisation. Working across R&D, Clinical, Regulatory, Quality, and Commercial functions. you will lead complex development workstreams and help bring high-quality, compliant diagnostic solutions to market. This is an exciting opportunity to influence strategic programmes while driving tangible business and patient impact.

Responsibilities

Project Leadership

Lead end-to-end IVD product development workstreams across assays, instruments, and software.
Collaborate with cross-functional teams to define project scope, timelines, milestones, and deliverables.
Partner with programme and principal project managers to ensure workstreams align with overall programme objectives.
Develop and maintain integrated project plans, ensuring alignment with the risk management strategy.
Drive execution to achieve cost, schedule, and performance objectives.

Cross-Functional Coordination

Collaborate with R&D, Clinical, Regulatory Affairs, Quality, Supply Chain, and Marketing teams.
Facilitate decision-making and alignment among senior stakeholders.
Ensure clear communication of project status, risks, issues, and mitigation plans.

Regulatory & Compliance

Ensure projects comply with global regulatory requirements, including IVDR, FDA 510(k), and CE marking.
Support design control activities, including Design History File maintenance, risk management, and validation.
Partner with regulatory teams to support submissions and approvals.

Risk & Issue Management

Identify and proactively manage risks, issues, and dependencies.
Develop mitigation and contingency plans.
Escalate critical project risks to programme leadership as appropriate.

Financial & Resource Management

Manage project budgets, forecasting, and resource allocation.
Monitor and optimise project costs.
Ensure effective utilisation of project resources.

Vendor & Partner Management

Manage relationships with external partners, CROs, and suppliers.
Oversee contracts, deliverables, and performance management activities.

Continuous Improvement

Promote and apply best practices in project management, including Agile, Hybrid, and Waterfall methodologies.
Drive improvements in processes, tools, and governance frameworks.
Support the development and growth of less experienced project managers.

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:

4-6 years of project management experience in IVD or life science related industry
Ability to demonstrate a successful track record in project managing successful product development
Preferable: Experience of managing product developments within a global regulatory framework (IVDRT/FDA)
Experience of project management tools and methodologies (waterfall, agile, MS project, Smartsheet’s)

Competencies:

Self-starting, growth mindset with the ability work independently and as part of a team.
Knowledge of IVD assay developmnet processes and procedures would be an advantage.
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.
Computer literate - knowledge of Word, PowerPoint and Excel an advantage - in order to produce reports, analyse data etc effectively

Travel (If Applicable): Ability to travel 20% for internal meetings/conferences.

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 innovation, our passionate team of ~16,000 colleagues turn scientific challenges into breakthroughs that improve lives worldwide.

Diversity and inclusion are fundamental to our core values at Waters Corporation. It benefits our employees, our products, our customers and our community. Waters complies with all applicable federal, state, and local laws. Qualified applicants are considered without regard to sex, race, color, ancestry, national origin, citizenship status, religion, age, marital status (including civil unions), military service, veteran status, pregnancy (including childbirth and related medical conditions), genetic information, sexual orientation, gender identity, legally recognized disability, domestic violence victim status, or any other characteristic protected by law. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. All hiring decisions are based solely on qualifications, merit, and business needs at the time.

Senior Project Manager

Job Description