QARA team internship
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-Bac +4/Bac+5 candidate (MSc/Meng) in biomedical engineering, life science, computer science, medical imaging, quality
Required skills:
- Knowledge of the European regulatory framework for medical devices EU MDR (Regulation (EU) 2017/745)
- Knowledge of the quality management system standards applicable for medical devices: ISO 13485
- Knowledge of the following standards is a plus: IEC 62304, IEC 62366-1
- Autonomous, structured, and rigorous
- Interest for medical devices in oncology, ideally in radiotherapy
- Experience in quality and regulatory affairs on medical device company is a plus
Languages:
- French
- English at a conversational level (International team)
Missions:
- Contributing to the maintenance of our quality management system according to the European regulation (MDR 2017/745) and international regulations applicable to medical devices
- Participating in the regulatory watch and the application of new regulations and standards
- Helping to define the certification policy for the company’s product in Europe and internationally
- Assisting the development team on the implementation and certification of an information security management system
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