Job description
Overview
Join Waters Advanced Diagnostics and help shape the future of clinical LCMS diagnostics. As a Project Manager 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.Join Waters Advanced Diagnostics and help shape the future of clinical LCMS diagnostics. As a Project Manager 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.Join Waters Advanced Diagnostics and help shape the future of clinical LCMS diagnostics. As a Project Manager 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.Join Waters Advanced Diagnostics and help shape the future of clinical LCMS diagnostics.Join Waters Advanced Diagnostics and help shape the future of clinical LCMS diagnostics.As a Project Manager 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.As a Project Manager 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.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 LeadershipSupport the end-to-end IVD product development project workstreams (assays, instruments, software)Assist cross-functional teams to define and project scope, timelines, milestones, and deliverablesWork 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 targetsCross-Functional CoordinationCollaborate with R&D, Clinical, Regulatory Affairs, Quality, Supply Chain, and MarketingCoordinate meetings, actions, and follow-ups across project teamsSupport clear communication of project updates and statusRegulatory & ComplianceEnsure 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 approvalsRisk & Issue ManagementIdentify and track project risks, issues, and dependenciesSupport development and monitoring of mitigation actionsEscalate risks to senior project or programme managers as neededFinancial & Resource ManagementSupport the management of project budgets, forecasting, and resource allocationTrack and optimize project costsEnsure efficient utilization of team resourcesVendor & Partner ManagementSupport the management of external partners, CROs, and suppliersSupport the management of contracts, deliverables, and performanceContinuous ImprovementFollow established project management processes and toolsContribute to improvements in PM practices and toolsDemonstrate willingness to learn and develop PM capabilityProject LeadershipSupport the end-to-end IVD product development project workstreams (assays, instruments, software)Assist cross-functional teams to define and project scope, timelines, milestones, and deliverablesWork 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 targetsCross-Functional CoordinationCollaborate with R&D, Clinical, Regulatory Affairs, Quality, Supply Chain, and MarketingCoordinate meetings, actions, and follow-ups across project teamsSupport clear communication of project updates and statusRegulatory & ComplianceEnsure 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 approvalsRisk & Issue ManagementIdentify and track project risks, issues, and dependenciesSupport development and monitoring of mitigation actionsEscalate risks to senior project or programme managers as neededFinancial & Resource ManagementSupport the management of project budgets, forecasting, and resource allocationTrack and optimize project costsEnsure efficient utilization of team resourcesVendor & Partner ManagementSupport the management of external partners, CROs, and suppliersSupport the management of contracts, deliverables, and performanceContinuous ImprovementFollow established project management processes and toolsContribute to improvements in PM practices and toolsDemonstrate willingness to learn and develop PM capabilityProject LeadershipSupport the end-to-end IVD product development project workstreams (assays, instruments, software)Assist cross-functional teams to define and project scope, timelines, milestones, and deliverablesWork 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 targetsCross-Functional CoordinationCollaborate with R&D, Clinical, Regulatory Affairs, Quality, Supply Chain, and MarketingCoordinate meetings, actions, and follow-ups across project teamsSupport clear communication of project updates and statusRegulatory & ComplianceEnsure 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 approvalsRisk & Issue ManagementIdentify and track project risks, issues, and dependenciesSupport development and monitoring of mitigation actionsEscalate risks to senior project or programme managers as neededFinancial & Resource ManagementSupport the management of project budgets, forecasting, and resource allocationTrack and optimize project costsEnsure efficient utilization of team resourcesVendor & Partner ManagementSupport the management of external partners, CROs, and suppliersSupport the management of contracts, deliverables, and performanceContinuous ImprovementFollow established project management processes and toolsContribute to improvements in PM practices and toolsDemonstrate willingness to learn and develop PM capabilityProject Leadership
Project LeadershipProject Leadership- Support the end-to-end IVD product development project workstreams (assays, instruments, 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
Cross-Functional Coordination
Cross-Functional CoordinationCross-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
Regulatory & ComplianceRegulatory & 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
Risk & Issue ManagementRisk & 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
Financial & Resource ManagementFinancial & 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
Vendor & Partner ManagementVendor & Partner Management- Support the management of external partners, CROs, and suppliers
- Support the management of contracts, deliverables, and performance
Continuous Improvement
Continuous ImprovementContinuous 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 fieldProject Management Professional (PMP) training or certification. Agile PM or equivalent type qualification preferableExperience:2-3 years of project management experience in IVD or life science related industryWillingness 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 an IVD product development lifecycle Competencies: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.Basis 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): 20% to Waters offices.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.Education:Bachelor’s degree in Life Sciences, Engineering, or related fieldProject Management Professional (PMP) training or certification. Agile PM or equivalent type qualification preferableExperience:2-3 years of project management experience in IVD or life science related industryWillingness 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 an IVD product development lifecycle Competencies: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.Basis 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): 20% to Waters offices.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.Education:Bachelor’s degree in Life Sciences, Engineering, or related fieldProject Management Professional (PMP) training or certification. Agile PM or equivalent type qualification preferableExperience:2-3 years of project management experience in IVD or life science related industryWillingness 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 an IVD product development lifecycle Competencies: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.Basis 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): 20% to Waters offices.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.Education:
Education:Education:- Bachelor’s degree in Life Sciences, Engineering, or related field
- Project Management Professional (PMP) training or certification. Agile PM or equivalent type qualification preferable
Experience:
Experience:Experience:- 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 an IVD product development lifecycle
Competencies:
Competencies:Competencies:- 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.
- Basis 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):
Travel (If Applicable):Travel (If Applicable):- 20% to Waters offices.
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.
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.