Hybrid Senior Regulatory Affairs Program Manager, Korean Speaking

at Sonio

• Job title: Senior Regulatory Affairs Program Manager, Korean Speaking
• Job type: Full Time
• Experience level: Senior
• Salary: €80,000 per year
• Degree requirement: Bachelor's Degree
• Tech skills: Cyber Security
• Location requirements: Hybrid, Paris, France

About the role

• Senior Regulatory Affairs Program Manager ensuring compliance for AI/ML medical devices at Sonio. Collaborating with regulatory bodies like the FDA for market access and sustained compliance.

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.

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.

Benefits

• 10% bonus