Sonio · 1 week ago
Senior Regulatory Affairs Program Manager (Korean speaking)
Boston, MA
Full-time
Hybrid
Senior Level
$75K/yr - $85K/yr
6+ years expSonio is a company focused on improving women's and children's health through technological innovation and medical expertise. They are seeking a Senior Regulatory Affairs Program Manager to develop and execute regulatory strategies for AI/ML-enabled medical devices, ensuring compliance with regulatory bodies such as the FDA.
Artificial Intelligence (AI)Health CareHealth DiagnosticsMedical Device
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
Qualification
Required
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
Benefits
10% bonus
Company
Sonio
Sonio is an AI-based support platform for fetal ultrasound, helping practitioners analyze and diagnose congenital malformations.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$30.15MKey Investors
European Innovation Council
2024-05-08Acquired
2023-07-11Series A· $14.32M
2022-12-19Seed· $7.96M
Leadership Team
Cecile Brosset
Co-founder & CEO
Remi Besson
Associé fondateur Sonio
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