We are looking for an intern to achieve a 6-month internship or a 1-year apprenticeship after the following mission :

• 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

Minimum level required:

• Bac +4/Bac+5 candidate (MSc/Meng) in biomedical engineering, life science, computer science, medical imaging, quality

Required skills:

• Good knowledge of the European regulatory framework for medical devices
• Good knowledge of the quality management system standard 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

Language:

• French
• English written and spoken