RAQA Manager

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