Regulatory Affairs Internship/Alternance
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 on healthcare professionals. They can also be a source of stress for 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.
Sonio's mission is to improve women's and children's health by promoting access and quality of care through technological innovation, medical expertise, and collective intelligence.
About the role
You will join our RAQA team and be attached to Zahra, Senior RAQA Manager.
Our team makes miracles happen and ensures our products are FDA-cleared, often in record time. During this experience, you’ll be at the heart of this team and learn how RA works in a tech startup.
Your role will be to support our team by continuously improving internal processes, ensuring regulatory compliance, and assisting with regulatory submission deliverables.
Key missions:
- Monitor and ensure the timely preparation and tracking of technical documentation related to design changes, in coordination with the relevant teams
- Assist in documentation preparation and publishing for regulatory submissions
- Assist in implementing an automated system for the regulatory and normative watch process
- Proactively monitor and ensure timely renewal of licenses, including Small Business Determination, Device Listing, and Establishment License for the US market
- Facilitate promotional marketing review by setting up a central...