Project Leader Job in Hasselt, Belgium

We develop and manufacture pharmaceuticals of the highest quality. We meet current and future customer needs through smart investments in R&D. We deliver best-in-class service and superior value. We celebrate the many cultures of our global team. We enhance the communities in which we live and work. We build shareholder value in all we do.

Project Leader Job Description

This position will provide project leadership in a development program whose objective is to bring to the market through CE mark and FDA clearance an in-vitro diagnostic kit. The job’s holder main duties and responsibilities are summarized below:

• Defining clear and comprehensive project goals aligned on business objectives. Defining, estimating, and planning project tasks with inter-dependencies to meet such goals. Identifying project risks and developing mitigation measures. Implementing project change requests and corrective actions to ensure project success
• Identifying and securing key project resources and managing resources to ensure adherence to the project plan
• Analyzing clinical data and working with the Medical Lead and the Clinical Affairs representative to achieve clinical objectives
• Adhering to corporate methodology, defining and reporting key measures of success
• Serving as technical lead in product development discussions
• Directly or through the project team, working effectively with business partners and vendors to achieve project objectives within the approved budget and timing. Closely monitoring vendor’s performance
• Consistently communicating to internal and external stakeholders outlining status, risks & issues

Project Leader Job Requirements

• The job holder must master the medical device and IVD product design and development process. He/She shall have a thorough understanding of the requirements of ISO 13485, 21CFR 820, Directive 93/42 EC and Directive 98/79 EC as well as of the GxP.
• Master Degree in Life Sciences is a must, PhD is an asset
• Minimum 3 years of experience in medical device development is a must, 5 years of experience is an asset.
• Fluent in English, any other foreign language is an asset.
• Flexible, result oriented, resistant to stress and strong team player.

Project Leader Application Information

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Project Leader Summary

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