Head of QARA, AI MedTech Regulatory Strategy

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

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.