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MUST HAVES:
– Experience in product development for medical products 
– Experience with regulations especially the new upcoming EU MDR requirements 
Please don't respond without one or both must haves!

Project Manager 
• Is involved in formulating the overall project assignment and having the assignment and plan approved by management, in consultation with the relevant functions and other stakeholders/parties involved, on base of requirements and business case. 
• Ensures Requirements and business case are defined, completed and approved 
• Builds and maintains the project organization, chooses the way of working and selects the adequate tools (tailors the approach to the specific project) and defines the interfaces with other functions, internal and external the organisation 
• Defines the risks of the project (f.e. specs, costs, planning, etcetera) and develops scenarios to overcome these risks. 
• Directs employees and gives them operational guidance, both technically and organizationally (where necessary, directs sub-Project Leaders). 
• Is responsible for implementation and realization according to the project plan (specification, quality, time, money, information) and organization. 
• Is responsible for quality initiatives to ensure quality deliverables of subsystems delivered. 
• Deploys process improvements and makes the project organization efficient and transparent, in line with departmental and project processes 
• Represents the project team in the business and provides business management with regular project performance status updates, variances to plan and identification of corrective actions 
• Manages internal and external stakeholders 
• Ensures that there is an effective transfer and archiving of the project results and the associated knowledge. 
• Reports on employees’ performance to the hierarchical superior of the employees for the purpose of appraisal and makes proposals for training the project members when shortcomings are observed. 
 

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