We are looking for a Quality and Regulatory work Engineer who is ready for the
challenge of bringing to a market of an AI-powered medical device that will transform the domain
of obstetric ultrasound; Someone who is ready to define our quality and regulation practice,
provide vision and leadership.
DIAGNOLY is a DeepTech start-up headquartered in Lyon, France.
Our aim is to improve fetal screening and simplify obstetric ultrasound technique for the
doctor. To do so, we develop an intelligent medical hardware device that will be connected to
ultrasound machines. Analyzing the fetal examination in real time, our product will help doctors
to detect the most complex fetal pathologies prenatally.
Increasing significantly prenatal detection rate of fetal pathologies, our product will reduce
the risk of lifelong disabilities, handicap or lethal outcomes for concerned babies.
- You are a former engineer or you have a technical background,
- You are curious and responsible person,
- You are independent but know how to work in a team.
- Co-Build our quality, regulatory and clinical strategy,
- Implement Diagnoly’s Quality Management System
- Implement and manage our pre-clinical and clinical studies, including necessary protocols
and related documents,
- Manage regulatory product compliance and regulatory submissions
- Preparation of CE marking technical file (Product risk assessment, guiding R&D team in in
compliant and effective design control/manufacturing processes),
- Technical education (MSc, PhD or equivalent)
- Knowledge of quality norms and regulatory obligations,
- Knowledge of legal obligations related to medical patient data and GDPR (General Data
- Successful experience of bringing to EU or US markets at least one medical device,
- First industrial experience
- Competitive salary (to be defined after the interview)
- Stock options / bonuses / additional vacation days
- Full remote work is not possible
If you are interested, you should definitely write us on