Senior Regulatory Affairs Program Manager (Koren speaking)

Sonio • Boston, MA

2d

About The Position

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’ll join a newly created team that will work on synergy projects between Sonio and Samsung. You’ll work on advanced technological projects mixing both hardware and software with cutting-edge AI/ML.
You will be responsible for developing and executing robust regulatory strategies, preparing high-quality submissions, and serving as the primary liaison with regulatory bodies like the FDA to ensure our innovative products meet all requirements for global market entry and sustained compliance.

Requirements

• Bachelor's degree in a scientific, engineering, or related discipline.
• 6+ years of regulatory affairs experience within the medical device industry.
• Demonstrated experience preparing and managing FDA submissions for software-based medical devices.
• In-depth knowledge of FDA guidance, risk management (ISO 14971), and quality management systems (ISO 13485, 21 CFR 820).
• Strong understanding of the Total Product Life Cycle (TPLC) for medical devices.
• Excellent written/verbal communication and project management skills.
• Exceptional written and verbal communication skills in English and Korean, with native or near-native fluency

Responsibilities

• Develop and implement comprehensive regulatory strategies for AI/ML-enabled medical devices to ensure timely and successful market access.
• Prepare, compile, and submit high-quality premarket submission files (e.g., 510(k)).
• Serve as the subject matter expert on FDA regulations and guidance pertinent to AI/ML and software-based medical devices.
• Act as a primary liaison with the FDA and other regulatory bodies, managing communications and leading negotiations.
• Monitor the regulatory environment for changes related to SaMD and cybersecurity and assess their impact.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 51-100 employees