Quality and Regulatory Manager M/F

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.
• Maintenance and improvement of the Quality Management System, including CAPA, change control, suppliers and complaints

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

Quality and Regulatory Manager M/F

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DIAGNOLY is a DeepTech start-up headquartered in Lyon, France. We are redefining obstetric and maternal-fetal medicine through real-time AI in ultrasound.

We are looking for an experienced Quality and Regulatory Engineer who is ready for the challenge of maintaining the certification and improving an AI-powered medical device that will transform the domain of obstetric ultrasound. We are seeking candidates who already have a strong background working within quality and regulation of software medical devices.

Responsibilities

• Definition of quality and regulatory strategies
• Preparation of the complete Design History Files (specifications, risk management, V&V) in collaboration with the R&D team
• Preparation and update of CE marking and 510(k) files
• Management of regulatory submissions and audits
• Maintenance and improvement of the Quality Management System, including CAPA, change control, suppliers and complaints

Requirements

• Excellent knowledge of MDR 2017/745, 21CFR, ISO 13485 and software standards and guidance
• Successful experience of bringing to EU or US markets at least one medical device of class IIa (or higher)
• At least 5 years of experience in the industry

Preferred

• Experience in AI software
• Good communication in French and English
• Motivated to grow and take on diverse responsibilities
• Startup experience

If you are interested, not hesitate to write to us on [e-mail]. Please provide your CV and a short motivation for this position in your email.