AI Medical Device Quality & Regulatory Lead

Diagnoly; Lyon; Sur place; EUR 70 000 - 110 000; Plein temps

Résumé du poste

A DeepTech start-up in Lyon seeks a Quality and Regulatory Manager to maintain certifications and improve AI-powered medical devices. Experience with MDR 2017/745, regulatory submissions, and managing quality systems is essential. The role offers an exciting opportunity to contribute to obstetric ultrasound advancements in a startup environment. Fluency in French and English is preferred, alongside a willingness to take diverse responsibilities.

Qualifications

• 5+ years of experience in the medical device industry.
• Experience bringing a class IIa (or higher) medical device to EU or US markets.
• Experience with regulations and quality management for medical devices.

Responsabilités

• Define quality and regulatory strategies.
• Prepare Design History Files in collaboration with R&D.
• Manage regulatory submissions and audits.
• Maintain and improve the Quality Management System.

Connaissances

Excellent knowledge of MDR 2017/745

Excellent knowledge of 21CFR

Excellent knowledge of ISO 13485

Excellent knowledge of software standards

Good communication in French

Good communication in English

Description du poste

A DeepTech start-up in Lyon seeks a Quality and Regulatory Manager to maintain certifications and improve AI-powered medical devices. Experience with MDR 2017/745, regulatory submissions, and managing quality systems is essential. The role offers an exciting opportunity to contribute to obstetric ultrasound advancements in a startup environment. Fluency in French and English is preferred, alongside a willingness to take diverse responsibilities.