Regulatory Affairs Intern

About the Company

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.

Responsibilities

• Monitor and ensure the timely preparation and tracking of technical documentation related to design changes
• 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
• Provide support for Post-market compliance activities

Requirements

• Ongoing Bac+5 in the medical devices field (engineering degree, master's in regulatory affairs, etc.)
• Fluency in French and English
• Interest in Sonio's mission
• Team-oriented mindset

Preferred Qualifications

• Knowledge in medical devices and software medical devices
• Knowledge in quality and regulatory affairs