Regulatory Affaires Internship/Alternance

Sonio SAS

Job Overview

Location

Paris office

Job Type

Full-time

Full Job Description

📋 Description

• This Regulatory Affairs Internship/Alternance at Sonio SAS supports the company’s mission to improve prenatal screening and diagnosis through AI-powered technology, ensuring products meet FDA and international regulatory standards to enhance women’s and children’s health.
• Day to day, you will monitor and track technical documentation for design changes, assist in preparing regulatory submissions, support automated regulatory watch systems, manage license renewals for the US market, facilitate marketing claim reviews, conduct regulatory compliance monitoring, and support post-market activities.
• You will join the RAQA team led by Senior RAQA Manager Zahra, working in a mission-driven startup that combines medical expertise from Necker Hospital and Ecole Polytechnique to innovate in prenatal medicine.
• In this role, you will gain hands-on experience in regulatory affairs within a tech startup, learn how to navigate FDA and ISO compliance processes, develop skills in documentation management and regulatory watch, and contribute to bringing safe, effective medical technologies to market faster.

🎯 Requirements

• Ongoing Bac+5 in the medical devices field (engineering degree, master's in regulatory affairs preferred)
• Knowledge in medical devices and/or software medical devices
• Knowledge in quality and regulatory affairs
• Perfect fluency in French and English
• Team-oriented mindset with strong collaboration skills

🏖️ Benefits

• Opportunity to work on impactful technology improving prenatal care and reducing diagnostic errors
• Hands-on experience in regulatory affairs within a fast-moving, innovative health tech startup
• Exposure to FDA clearance processes and international regulatory standards (ISO)
• Collaborative team environment focused on well-being, transparency, and innovation
• Structured internship/alternance with clear timeline: response within a week, offer within a month

Skills & Technologies

Junior

Onsite

Degree Required

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Sonio SAS

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About Sonio SAS

French medical-device software firm developing AI-based prenatal ultrasound decision-support tools. Founded in 2019, the company offers cloud applications that analyze fetal ultrasound images to detect anomalies, guide exam protocols, and generate structured reports for obstetricians and maternal-fetal medicine specialists across Europe and North America.

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