06 Fév [2018-02] Medical Device Project Manager – Filled
Medical Device Project Manager – Filled
CellProthera is a biotech company based in Mulhouse (FR) developing innovative cell therapy products based on a proprietary cell processing technology platform. A multi-center Phase I/IIb clinical trial is currently on-going in Europe and Singapore in patients having suffered from severe acute myocardial infarction.
Your mission
Under supervision of the Development and Industrialization Director, you will ensure the development of medical devices – cell expansion device and fluidic kits. In this respect, you will:
- Manage internal and external participants (7 industrial partners) in the cell expansion device development project by maintaining efficient communication, supervision and reporting
- Develop long-term, trust relationship with partners in order to maintain their commitment to the project
- Verify accuracy and completeness of technical documentation
- Perform functional routine against objectives and provide sufficient updates
- Work with R&D and Regulatory teams to prepare technical documentation and validation of protocols, realize tests and write reports and qualify equipment
- Provide technical support to external cell manufacturing partners
- Followup and apply in everyday work current industry standards and regulations
Your profile
- Scientific qualification Biomedical engineer or equivalent
- A minimum of 3 years’ experience in medical device development or/and industrialization
- Knowledge of Medical Device Directive, CE marking, ISO 13485, FDA regulations
- Self-driven with excellent communication, reporting and analytical skills and teamwork
- Rigorous, hard-working, result-oriented, troubleshooting and hands-on person
- English fluent. French conversational
Applicants should also be entitled to work within the European Economic Area (EEA) and willing to travel worldwide (10-25%)
Position in Mulhouse (Fr). If you are interested in this job, please contact Paula Lee (plee@cellprothera.com)