Quality and Regulatory Affairs - Internship

TheraPanacea est une start-up dans le domaine des technologies médicales qui exploite l‘intelligence artificielle, l’imagerie médicale et les mathématiques avancées pour révolutionner la prise en charge du cancer.

Créée en 2017, TheraPanacea a reçu plusieurs prix nationaux et internationaux récompensant l’innovation et l’excellence scientifique de ses produits et projets dont le prix européen de la Recherche (European Research Council grant) en 2016 et en 2018 le 1er Prix du Paris Région AI Challenge.

Ses bureaux sont situés au cœur de Paris (RER B Port- Royal) et vous rejoindrez une équipe passionnée, dynamique et internationale (10 nationalités différentes).

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