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Quality Assurance and Regulatory Affairs (QARA) – F/H

Présentation société

Raidium develops a radiological foundation model embedded in an AI-native PACS Viewer for Radiologists.

About Us: Raidium develops a radiological foundation model embedded in an AI-native PACS Viewer for Radiologists. This new generation of AI will enable the building of an imaging biomarker factory for both clinical practice and research, tackling the complexity of precision medicine. We raised a €16m Seed round in November 2024 and are growing very fast! The Role: As a QARA Intern, you’ll work directly with our QARA Manager to build and maintain our Quality Management System (QMS) and support key regulatory submissions for the U.S. (FDA) and Europe (EU MDR). This is a hands-on role where you’ll learn the ropes of quality and compliance in the med-tech world while making a real impact. What You’ll Do:

• QMS Support: Help design, document, and maintain our QMS.
• Regulatory Submissions: Assist with FDA submissions and EU certifications (510(k), CE marking).
• Documentation: Draft SOPs, manage document control, and assist with internal audits.
• Teamwork: Collaborate with R&D teams (machine learning researchers, engineers, and software engineers) to ensure compliance to standards.

Why us:

• Join a very promising, well funded early stage start-up
• Learn the ins and outs of medtech quality and regulatory work.
• Help launch a game-changing product in healthcare.
• Have a real and positive impact on people’s lives
• Work with a diverse team of engineers and medical doctors

Details: 

• Duration: 6 months.
• Opportunity to join the team full-time after the internship.
• Location: Hospital Cochin (Port Royal, Paris 14).
• Salary: 1600-1900€/month.

Descriptif du profil

• Studying in Biomedical Engineering, Quality/Regulatory Affairs, or similar.
• Good knowledge of ISO 13485, ISO 14971, IEC 62304 standards, and European MDR regulation.
• Detail-oriented and organized, with strong communication skills.
• Bonus: Know your way around SaMD, AI, or radiology.

Postuler

Dabouineau Laetitia
laetitia.dabouineau@raidium.eu