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Project Leader Product Development Paris France,  


Posted on : 05 May 2017

Project Description

As a Project Leader Product Development, you will help transfer MLPA products from research use only (RUO) to in vitro-diagnostics (IVD) status, to guarantee our products can safely be used to diagnose patients. MRC-Holland offers a young and dynamic working environment with good connections to labs worldwide and an opportunity to contribute to products that make a difference in a patient s life. Responsibilities Creating in-depth knowledge on the clinical background of individual MLPA products for determining and evaluating their intended use, diagnostic/clinical validity, etc. This can be achieved by performing literature reviews, attending conferences, contacting external experts, etc. Reviewing and evaluating the product s design, and improve if necessary. Creating and evaluating various design control deliverables, such as product risk analyses, design and development plans, and literature study reports. Moderating and chairing design review meetings. Writing, editing and maintaining technical documentation in line with relevant regulatory requirements. Maintaining clear and effective communication with other departments within MRC-Holland and processing their input. Contributing to company-related processes, such as quality assurance. Qualifications PhD degree in Biology or Biomedical Sciences is preferred (starter). Required competences Adequate knowledge on genetics. Affinity with procedures and systems. Well-developed analytical skills. Precise, detailed and flexible. Ability to meet deadlines. Able to work alone as well as part of a team. Advanced writing and communication skills in English.

Locations

75011 Paris France

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