QARA team internship

Therapanacea; Paris; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

Therapanacea in Paris seeks a candidate with a Bac+4/5 in biomedical engineering or related fields to contribute to quality and regulatory affairs for medical devices. You will help maintain the QMS per MDR and ISO 13485, monitor regulatory changes, and assist in defining worldwide certification policies.

The role favors autonomous, structured individuals with interest in oncology devices and experience in medical device regulatory affairs.

Qualifications

• Knowledge of EU MDR and ISO 13485 required.
• Experience with medical device regulatory affairs is a plus.
• Interest in oncology/radiotherapy medical devices.

Responsabilités

• Maintain quality management system per MDR 2017/745 and international regs.
• Monitor regulatory changes and apply new standards.
• Define certification policy for Europe and international markets.
• Assist dev team with information security management system certification.

Connaissances

EU MDR knowledge

ISO 13485

IEC 62304/62366-1

Autonomous

Oncology devices interest

Regulatory affairs experience

French

English conversational

Formation

Bac+4/Bac+5 candidate in biomedical engineering

Description du poste

-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