Senior Project Manager

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.

• 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.

• 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.

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

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

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

• 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.

• 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)

• 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