Quality & Regulatory Engineer for AI Medical Devices

Therapanacea; Paris; On-site; EUR 70,000 - 90,000; Full time

Job summary

TheraPanacea, a medical technology company focused on AI to improve cancer care, is seeking a Regulatory & Quality professional in France. The role ensures compliance with MDR and global standards, maintains the quality and information security management systems, and supports the development of controlled documents and training materials.

The ideal candidate has 2+ years in quality/regulation for software-like medical devices in Europe, is autonomous and highly organized, and communicates

Qualifications

• 2+ years of quality and regulation experience in software-like medical devices or medical platforms in Europe.
• Fluency in English (written and spoken).
• Autonomous, structured, and rigorous with strong organizational skills.
• Experience with international certifications is a plus.

Responsibilities

• Contribute to maintaining the quality system per MDR 2017/745 and ISO13485.
• Manage and optimize the quality management system toward broader applications.
• Oversee information security management per ISO27001 (and related standards).
• Write and maintain controlled documents.
• Monitor key performance indicators and prepare reports.
• Create training modules on quality processes and assessments.

Skills

Regulatory compliance

ISO 13485

MDR 2017/745

21 CFR 820

Information security awareness

Communication skills

Project management

Job description

TheraPanacea, a medical technology company focused on AI to improve cancer care, is seeking a Regulatory & Quality professional in France. The role ensures compliance with MDR and global standards, maintains the quality and information security management systems, and supports the development of controlled documents and training materials.

The ideal candidate has 2+ years in quality/regulation for software-like medical devices in Europe, is autonomous and highly organized, and communicates