Sonio
Regulatory Affairs Internship/Alternance
3w ago
EuropeTraineeRemoteregulatory complianceprocess improvementregulatory submissions
Internship role supporting regulatory affairs and quality assurance team in a medical tech startup focused on prenatal screening AI solutions.
Responsibilities
- 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
Other
- 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.
- 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