Quality and Regulatory Affairs Specialist – F/H
Région : Île-de-France
Rémunération : entre 40K€ et 50K€
Famille de métier : Réglementaire, Qualité
Présentation société
At Sonio, we use Artificial and collective Intelligence to improve access and quality of care for women and children, to secure pregnancy care and to empower fetal ultrasound practitioners.
About Sonio
Each year, 140M children are born. Birth defects affect 1 in 33 births in developed countries, and in 50% of cases, they are not detected during prenatal examinations. Prenatal medicine is particularly complex, and the scans impose heavy responsibilities for the healthcare professionals. They can also be a source of stress for the future parents.
Resulting from 5 years of collaboration between world-renowned experts from Necker Hospital and Ecole Polytechnique, Sonio uses artificial intelligence to improve prenatal screening and diagnosis. Based on patented algorithms and a proprietary expert database, Sonio aims to become the reference tool to help practitioners improve screening, reduce diagnostic errors, and optimize pregnant women’s medical path.
About the role
You’ll be working hand-to-hand with the Head of RAQA and the aim is for you to progress and be able lead key project (FDA approval, CE mark):
- Implement the quality management system in accordance with the applicable regulations (ISO 13485, FDA 21 CFR…)
- Create, implement, and monitor appropriate quality procedures
- Train and support the entire team in maintaining good practices and procedures
- Support the execution of internal audits
- Analyze and manage customer complaints, non-conformities and CAPA
- Participate in writing and update of Technical Documentation according to MDR 2017/745 requirements
- Ensure regulatory activities related to product development and/or product modification in the context of medical device registrations
- Support product registration in target countries
- Participate in regulatory monitoring activities
Descriptif du profil
- Engineering Degree or MsC in Regulatory Affairs or Medical/Scientific field
- 1-2 years of experience in a quality and regulatory affairs position for medical devices
- Familiar with EU regulation (MDR 2017/745) and QMS regulation (ISO 13485, 21 CFR)
- Great capacity for relational adaptation to integrate a young dynamic team
- Great technical skills and operational excellence
- Proactivity and will to achieve ambitious goals
- Transparency, humility and respect
- Good level of English (written/oral)
Postuler
Clément Moreau
clement.moreau@sonio.ai