Senior Regulatory Affairs Program Manager (Koren speaking)

Sonio(25 days ago)

HybridFull TimeSenior$82,350 - $93,330ProdOps

About this role

The Senior Regulatory Affairs Program Manager at Sonio is responsible for developing and executing regulatory strategies for AI/ML-enabled medical devices, ensuring compliance with FDA and other regulatory bodies for global market access. This role involves preparing high-quality premarket submissions, acting as a subject matter expert on relevant regulations, and managing communications with regulatory agencies. The position requires strong expertise in regulatory affairs within the medical device industry, particularly regarding software-based devices, and involves initial work in Paris or Boston before transitioning to Seoul, Korea. Fluency in English and Korean is essential for effective communication and collaboration.

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Required Skills

Regulatory Strategies
Market Access
FDA Submissions
Subject Matter Expert
Liaison Management
Regulatory Environment Monitoring
Bachelor's Degree
Regulatory Affairs Experience
Medical Device Industry
FDA Guidance Knowledge

+7 more

Qualifications

Bachelor's degree in a scientific, engineering, or related discipline

About Sonio

sonio.ai

Sonio is an innovative provider of cloud-based ultrasound reporting software specifically designed for OB-GYN practices. Utilizing advanced clinical AI, Sonio enhances efficiency and quality control in ultrasound workflows, allowing healthcare professionals to generate reports quickly and ensure the accuracy of examinations. The platform supports seamless integrations with existing healthcare systems and prioritizes data security through compliance with robust regulatory standards. Sonio's mission is to empower healthcare workers to deliver high-quality prenatal care globally.