QARA Apprentice

Raidium; Paris; Sur place; EUR 2 000; Plein temps

Résumé du poste

Join a promising early-stage startup as a QARA apprentice, where you'll work with the QARA Manager to build and maintain the Quality Management System and support regulatory submissions. This hands-on role offers a unique opportunity to learn about quality and compliance in the med-tech industry while making a real impact on healthcare.

Prestations

Opportunity to join the team full-time after apprenticeship

Competitive salary

Qualifications

• Studying in Biomedical Engineering or Quality/Regulatory Affairs.
• Good knowledge of ISO standards and European MDR regulation.

Responsabilités

• Help design, document, and maintain the Quality Management System.
• Assist with FDA submissions and EU certifications.
• Draft SOPs and manage document control.

Connaissances

Detail-oriented

Strong communication skills

Formation

Biomedical Engineering

Quality/Regulatory Affairs

Outils

ISO 13485

ISO 14971

IEC 62304

Description du poste

About Us:

Raidiumdevelops 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 apprentice, 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.

About You:

• 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.

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: 1 year.
• Opportunity to join the team full-time after the apprenticeship.
• Location: Hospital Cochin, (Port Royal, Paris 14).
• Competitive salary of 1600€ brut/month.