Overview In this role you will lead coordination of end-to-end IVD software development programs, aligning cross-functional teams to deliver LC-MS diagnostic solutions that meet regulatory and quality standards. You will drive integrated planning, risk management, and cost control while partnering with R&D, Regulatory, Quality, and Commercial teams to enable patient-impacting products. The position offers growth in a fast-paced, collaborative environment with a focus on continuous PM capability improvement. This is a hands-on role with a clear impact on program success and regulatory compliance.
Pay / Benefits - flexible work arrangements
- 25 days holidays
- attractive employer pension contribution
- life assurance
- income protection
- private medical
Responsibilities - Support end-to-end IVD software development project workstreams
- Define scope, timelines, milestones, and deliverables with cross-functional teams
- Link workstreams to overall program goals and maintain integrated project plans
- Manage execution to meet cost, schedule, and performance targets
- Coordinate meetings and actions across project teams
- Communicate project updates and status clearly
- Ensure compliance with IVDR, FDA 510(k), CE marking and support design history file and risk management
- Identify and track risks, issues, and dependencies; escalate as needed
- Support budgets, forecasting, and resource allocation; optimize costs
- Assist management of external partners, CROs, and suppliers; track contracts and performance
- Follow PM processes and contribute to tool improvements
- Demonstrate willingness to learn and develop PM capability
Key requirements - Bachelor in Life Sciences or Engineering
- PMP certification; Agile PM or equivalent preferable
- 2–3 years of project management experience in IVD or life science
- Experience in software development life cycle and regulatory context
- Excellent written and oral communication skills
- Computer literacy with Word, PowerPoint, Excel
- Experience managing software development projects in regulated environments
- Strong communication
- Cross-functional collaboration
- Attention to detail
- MS Project
- Smartsheet
- Agile and Waterfall methodologies
