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Project Manager
2 months ago
Agilent Technologies is seeking an experienced Project Manager to join our In Vitro Diagnostic Medical Devices (IVDR) Program Office in Glostrup, Denmark. The successful candidate will lead project teams to successfully transition Agilent Pathology products to IVDR, applying project management skills and understanding of medical devices/IVDs.
Main Responsibilities:
- Lead one or more projects to transition current cancer diagnostic IVDD products to IVDR, including delivery of technical file documentation, submission to a notified body, and ensuring manufacturing readiness.
- Develop project plans, budgets, and resource plans in collaboration with stakeholders.
- Lead geographically diverse, cross-functional project teams, including Marketing, Research and Development, Regulatory, Quality Assurance, and Manufacturing.
- Communicate project status, progress, and challenges effectively.
- Manage project risks, including identification, mitigation, and contingency planning.
- Manage relationships and inter-dependencies with other projects and related activities.
- Motivate and encourage team members.
- Act independently to identify and resolve challenges.
Qualifications:
- A relevant Master's background related to Life Science or Engineering.
- Experience with coordination of project teams and proven success in delivering results in a highly regulated industry.
- Solid understanding of working with design control documentation for in vitro diagnostic or medical devices.
- Strong collaboration, stakeholder management, and communication skills to align and set direction for project teams.
- Excellent English verbal/written communications skills.
- Problem-solving, planning, and analytical skills.
- Ability and flexibility to manage uncertainty, ambiguity, and changes in direction in a fast-paced work environment.
- Knowledge of IVDR is a plus.
- Certification in Project Management (e.g., Prince2, IPMA, PMP) is a plus.
