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Quality and Regulatory Work Engineer
Il y a 5 mois
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.
- Start-up activity_
DIAGNOLY is an early-stage DeepTech start-up headquartered in Lyon, France. Our aim is to improve fetal screening and simplify decision making during obstetric ultrasound. To do so, we develop an ai-powered medical device analyzing fetal examination in real time for improving children’s outcomes.
**Responsibilities**:
- Definition of quality, regulatory and clinical strategy,
- Preparation and quality analysis of medical data. Writing of study reports,
- Preparation of CE marking technical file (Product risk assessment, guiding R&D team in in compliant and effective design control/manufacturing processes),
- Implementation and management of pre-clinical and clinical studies. Implementation of necessary protocols and related documents,
- Managing relationships with a consulting company, CROs and suppliers.
- Requirements:_
- Technical education
- Huge motivation
- Knowledge of legal and regulatory obligations related to medical patient data (images, videos) and GDPR (General Data Protection Regulation);
- Preferred_
- Industrial experience
- Successful experience of bringing to EU or US markets at least one medical device of class IIa (or higher),
- Experience of collaboration with healthcare system (doctors, clinics, hospitals),
- Startup experience;
Type d'emploi : Temps plein, CDI
Salaire : 35 000,00€ à 45 000,00€ par mois
Avantages:
- Participation au Transport
- RTT
Programmation:
- Périodes de travail de 8 heures
- Travail en journée
Types de primes et de gratifications:
- Prime annuelle
Lieu du poste : Un seul lieu de travail