Head of QARA

Raidium; Paris; Hybrid; EUR 110,000 - 150,000; Full time

Job summary

Raidium is seeking a Head of QARA to define our regulatory strategy and ensure AI-native solutions meet safety and quality standards. You will lead global MDR/FDA submissions and coordinate technical files, clinical data, and audits.

You will mentor a junior QARA, maintain the QMS, and collaborate with R&D and Product to embed Compliance by Design into our software as a medical device.

Qualifications

• 5+ years of experience in Regulatory Affairs and Quality Assurance within the medical device industry.
• Master’s degree in Life Sciences, Engineering, or Law.
• Solid track record with MDR and/or FDA submissions.
• Experience with ISO 13485 and maintaining/auditing QMS.
• Willingness to work in AI-healthcare and SaMD.
• Authorization to work in France with 2 days in the office.
• Fluency in English with strong communication skills.

Responsibilities

• Lead the global regulatory strategy (MDR, FDA) to bring AI medical devices to market.
• Manage submission processes, coordinating technical files and clinical data.
• Mentor a Junior QARA and support their growth.
• Maintain and improve the QMS as the company scales.
• Be the main contact for Notified Bodies and authorities.

Skills

Regulatory affairs

Quality assurance

MDR/FDA

ISO 13485

SaMD

Regulatory leadership

Education

Master’s degree in Life Sciences

Master’s degree in Engineering

Master’s degree in Law

Tools

QMS

Job description

About the company

Raidium is building a foundation Model for precision medicine in radiology. Our first release, Curia is already state of the art. We aim to broadly democratize access to imaging biomarkers for both clinical and research applications through a biomarker factory. Our model is embedded in a new type of solution for the radiologist that enables a revolutionary AI-native workflow. Thanks to a 16M€ seed round raised in November 2024, Raidium is expanding its team.

We are developing a medical device designed to operate at the intersection of deep learning and diagnostic precision. While our Quality Management System (QMS) is already established and operational, we are now entering a critical phase of our growth. We have initiated the formal regulatory pathways (MDR/FDA) to bring our AI-native solutions to the global market.

The team

The founders of Raidium are experts in radiology and machine learning from Owkin, bringing together extensive experience from both fields.

• Paul Herent, CEO, is a radiologist and former interne des hôpitaux de Paris, with a Cogmaster (ENS) and PSL background, and has published pioneering research on deep learning in radiology.
• Pierre Manceron, CTO, is a Centrale Paris engineer specialized in Applied Mathematics and Machine Learning, who previously led machine learning projects at Owkin.
• Sebastian Schwarz, COO, holds a double degree in X-HEC Data Science & Business, who previously worked as a Strategy & Operations Director at Owkin, where he developed Owkin’s strategic vision and operational agency.

Our team brings together strong academic foundations (Polytechnique, Ponts, MVA) and deep medical, AI, and business experience from leading medical and tech companies such as Owkin, Cardiologs, Datadog, and Meta, all united by a mission to revolutionize radiology through cutting‑edge technology.

The role

As the Head of QARA at Raidium, you will play a pivotal role in defining our regulatory strategy and ensuring our AI-native solutions meet the highest standards of safety and excellence.

• Lead the global regulatory strategy (MDR, FDA) to get our AI medical devices to market
  Manage the submission process, coordinating technical files and clinical data to secure product certifications and clearances.
• Manage and mentor a Junior QARA, overseeing their daily tasks and supporting their professional growth within the team.
• Maintain and improve our QMS, keeping our quality processes lean and effective as the company scales.
• Act as the main contact for Notified Bodies and authorities, handling all external audits and regulatory communications.
• Partner with R&D and Product teams to ensure "Compliance by Design," guiding the team through risk management and software standards.

You

• At least 5 years of experience in Regulatory Affairs and Quality Assurance within the medical device industry.

• Master’s degree in Life Sciences, Engineering, Law, or a related technical field.

• Solid track record with Medical Device regulations, specifically MDR (EU) and/or FDA (US) submissions.

• Experience with ISO 13485, including maintaining or auditing a Quality Management System.

• Willingness to work in the AI-healthcare industry, with a passion for software-as-a-medical-device (SaMD).

• Authorization to work in France and willing to come to the office (2 days remote policy).

• Fluency in English, with excellent communication and teamwork skills.

Pluses (not exhaustive)

• Experience with AI/ML specific regulations (e.g., AI Act or FDA AI frameworks).

• Familiarity with software standards

• Previous experience in astart-up or scale-up environment.

• Experience managing or mentoring junior staff.

• Knowledge ofRadiology workflows

Why join us

• Have a real and positive impact on people’ live
• Be in contact with radiologists in our partner centers
• Work with a team of internationally recognized experts
• Work with a diverse team of engineers and medical doctors
• Competitive salary