Job description
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.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.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.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.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.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.This is an exciting opportunity to influence strategic programmes while driving tangible business and patient impact.Responsibilities
Project LeadershipLead 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 CoordinationCollaborate 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 & ComplianceEnsure 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 ManagementIdentify and proactively manage risks, issues, and dependencies.Develop mitigation and contingency plans.Escalate critical project risks to programme leadership as appropriate.Financial & Resource ManagementManage project budgets, forecasting, and resource allocation.Monitor and optimise project costs.Ensure effective utilisation of project resources.Vendor & Partner ManagementManage relationships with external partners, CROs, and suppliers.Oversee contracts, deliverables, and performance management activities.Continuous ImprovementPromote 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.Project LeadershipLead 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 CoordinationCollaborate 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 & ComplianceEnsure 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 ManagementIdentify and proactively manage risks, issues, and dependencies.Develop mitigation and contingency plans.Escalate critical project risks to programme leadership as appropriate.Financial & Resource ManagementManage project budgets, forecasting, and resource allocation.Monitor and optimise project costs.Ensure effective utilisation of project resources.Vendor & Partner ManagementManage relationships with external partners, CROs, and suppliers.Oversee contracts, deliverables, and performance management activities.Continuous ImprovementPromote 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.Project LeadershipLead 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 CoordinationCollaborate 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 & ComplianceEnsure 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 ManagementIdentify and proactively manage risks, issues, and dependencies.Develop mitigation and contingency plans.Escalate critical project risks to programme leadership as appropriate.Financial & Resource ManagementManage project budgets, forecasting, and resource allocation.Monitor and optimise project costs.Ensure effective utilisation of project resources.Vendor & Partner ManagementManage relationships with external partners, CROs, and suppliers.Oversee contracts, deliverables, and performance management activities.Continuous ImprovementPromote 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.Project Leadership
Project LeadershipProject LeadershipLead 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 CoordinationCollaborate 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 & ComplianceEnsure 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 ManagementIdentify and proactively manage risks, issues, and dependencies.Develop mitigation and contingency plans.Escalate critical project risks to programme leadership as appropriate.Financial & Resource ManagementManage project budgets, forecasting, and resource allocation.Monitor and optimise project costs.Ensure effective utilisation of project resources.Vendor & Partner ManagementManage relationships with external partners, CROs, and suppliers.Oversee contracts, deliverables, and performance management activities.Continuous ImprovementPromote 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.- 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
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
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
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
Financial & Resource Management- Manage project budgets, forecasting, and resource allocation.
- Monitor and optimise project costs.
- Ensure effective utilisation of project resources.
Vendor & Partner Management
Vendor & Partner Management- Manage relationships with external partners, CROs, and suppliers.
- Oversee contracts, deliverables, and performance management activities.
Continuous Improvement
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 industryAbility 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 effectivelyTravel (If Applicable): Ability to travel 20% for internal meetings/conferences.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 industryAbility 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 effectivelyTravel (If Applicable): Ability to travel 20% for internal meetings/conferences.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 industryAbility 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 effectivelyTravel (If Applicable): Ability to travel 20% for internal meetings/conferences.Education:
Education:Education:• Bachelor’s degree in Life Sciences, Engineering, or related field• Project Management Professional (PMP) certification. Agile PM or equivalent type qualification preferable
• Bachelor’s degree in Life Sciences, Engineering, or related field• Project Management Professional (PMP) certification. Agile PM or equivalent type qualification preferable•Experience:
Experience: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:
Competencies: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.
Travel (If Applicable): Ability to travel 20% for internal meetings/conferences.Travel (If Applicable):