Paris, Ile-de-France, France · Hybrid
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 comple…
Skills: Regulatory Affairs, Quality Assurance, FDA Compliance, ISO Standards, Technical Documentation
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Support the RAQA team by improving internal processes and ensuring regulatory compliance for FDA-cleared products. Key tasks include preparing technical documentation for design changes and monitoring regulatory and normative requirements.
Candidates should be pursuing a Master's degree (Bac+5) in medical devices, regulatory affairs, or engineering. Fluency in both English and French is required, along with a strong interest in the company's mission.
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.
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 centralized database of validated marketing and clinical claims
Perform regulatory watch to ensure compliance with FDA regulations, ISO standards, and other relevant regulatory requirements and provide support for regulatory impact analysis
Provide support for Post-market compliance activities
Sonio is a mission-driven company so interest in our mission is critical. Other requirements are:
Ongoing Bac+5 in the medical devices field in preference (engineering degree, master's in regulatory affairs…)
Knowledge in medical devices, and software medical devices is a plus
Knowledge in quality and regulatory affairs is a plus
You are perfectly fluent in French and English
You value teamwork and you are team-oriented. This role will interact with most internal teams. Moreover, happiness and well-being are a priority in the way we’re building the team and we also want to be innovative here!
Location: Paris
We move fast and aspire to be transparent over the process - our objective is that the process from the first chat to an offer is no longer than a month. We also aspire to give an answer to every application in a week - if you have not heard from us, please follow up at [email protected].
Securing pregnancy care
Sonio, a wholly-owned subsidiary of Samsung Medison Co., Ltd since 2024, is a highly customizable workflow and practice management solution powered by AI for automation, efficiency, and quality control. "Sonio AI-enhanced¹ software empowers ultrasound practitioners and readers. Sonio assists them in performing every prenatal examination to their highest quality standards, ensuring the completeness of each examination, streamlining their workflow, and in prenatal diagnosis. Sonio is based on over five years of research and collaboration between leading experts in fetal medicine and AI. ¹AI-enhancement is provided by FDA 510(k) cleared Sonio Detect product * Applicable to V1 only, Data enclosed at Sonio **See table 6 in the 510k summary: https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240406.pdf
Offices: Boston , US · 27 E 28th St, New York, NY 10016, US
Securing pregnancy care
Sonio, a wholly-owned subsidiary of Samsung Medison Co., Ltd since 2024, is a highly customizable workflow and practice management solution powered by AI for automation, efficiency, and quality control. "Sonio AI-enhanced¹ software empowers ultrasound practitioners and readers. Sonio assists them in performing every prenatal examination to their highest quality standards, ensuring the completeness of each examination, streamlining their workflow, and in prenatal diagnosis. Sonio is based on over five years of research and collaboration between leading experts in fetal medicine and AI. ¹AI-enhancement is provided by FDA 510(k) cleared Sonio Detect product * Applicable to V1 only, Data enclosed at Sonio **See table 6 in the 510k summary: https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240406.pdf
Offices: Boston , US · 27 E 28th St, New York, NY 10016, US
