QARA Intern: MedTech Quality & Regulatory (EU MDR)

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

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.