Quality and Regulatory Manager M/F

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 Please provide your CV and a short motivation for this position in your email.