QARA team internship

-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