Quality and Regulatory Affairs Specialist – F/H
Région : Île-de-France
Niveau de formation : > Bac + 5
Rémunération : entre 40K€ et 50K€
Famille de métier : Qualité
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.
Sonio’s mission is to improve detection, diagnosis and care of congenital malformations and rare diseases, thus improving parents’ journey throughout pregnancy, enabling better outcomes for the future baby, reducing liability for physicians and reducing healthcare costs.
Today, Sonio develops an AI-enabled software, used by sonographers and ob/gyns during fetal ultrasound examination to improve their diagnostic performance. The technology relies on two patented algorithms and an expert proprietary database. As a standalone software, Sonio’s first product, Sonio Diagnostics, is an intelligent decision tree, using only inputs from practitioners and real-time computing multiple type of data (phenotype, genotype, blood tests) to guide towards the next most probable sign and diagnosis. We help diagnose benign anomalies as well as rare genetic diseases or other polymalformative syndromes. Our everyday motivation is to see our technology improve the daily routine of physicians and daily life of future moms and children all around the world.
We believe that team matters above all things. We want to create a balanced culture, valuing operational excellence as much as care for each other and for the project, putting medical value at the core. We believe that by understanding the needs and issues we contribute to solve, we will create the most economic value. We want to create a place where everybody is thrilled to come to work and succeeds professionally.
Our product roadmap is broad. Our strategy is to grow fast and become an international standard of care for prenatal diagnosis, fetal ultrasound and pregnancy care.
The RAQA specialist will join the RAQA team under the supervision of the RAQA Manager to help: secure our compliance with Quality and Regulatory requirements for Sonio’s products for prenatal diagnosis, fetal ultrasound and pregnancy care, in all relevant geographies.
- 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)