Start-up activity
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