Regulatory Strategy Lead, AI/ML Medical Devices

Sonio; Paris; Hybride; EUR 60 000 - 80 000; Plein temps

Résumé du poste

A cutting-edge medical technology firm in Paris seeks an experienced Regulatory Affairs professional to develop innovative regulatory strategies for AI/ML-enabled medical devices. This role involves preparing submissions, serving as a liaison with regulatory bodies, and ensuring compliance. Ideal candidates will have over 6 years of relevant experience, strong communication skills in English and Korean, and a Bachelor's degree in a relevant discipline. A competitive salary package is offered, alongside opportunities for international relocation.

Qualifications

• 6+ years of regulatory affairs experience within the medical device industry.
• Demonstrated experience preparing and managing FDA submissions for software-based medical devices.
• Strong understanding of the Total Product Life Cycle (TPLC) for medical devices.

Responsabilités

• Develop and implement regulatory strategies for AI/ML-enabled medical devices.
• Prepare high-quality premarket submission files (e.g., 510(k)).
• Serve as the subject matter expert on FDA regulations.

Connaissances

Regulatory affairs experience

FDA submissions

Risk management (ISO 14971)

Quality management systems (ISO 13485)

Project management

Bilingual in English and Korean

Formation

Bachelor's degree in a scientific, engineering, or related discipline

Description du poste

A cutting-edge medical technology firm in Paris seeks an experienced Regulatory Affairs professional to develop innovative regulatory strategies for AI/ML-enabled medical devices. This role involves preparing submissions, serving as a liaison with regulatory bodies, and ensuring compliance. Ideal candidates will have over 6 years of relevant experience, strong communication skills in English and Korean, and a Bachelor's degree in a relevant discipline. A competitive salary package is offered, alongside opportunities for international relocation.