[Summary of the Role]As a Regulatory Affairs Professional, you will play a key role in ensuring regulatory compliance throughout the product lifecycle of ultrasound systems, catheters, and transducers — including those with AI-powered features. He or she will collaborate with cross-functional teams and international regulatory stakeholders to support global product registrations and enable market access. This role is especially critical in driving regulatory strategy and execution for catheter-related registrations and next-generation systems incorporating artificial intelligence.[Job Scope/ Responsibilities]- Lead or support regulatory submissions for ultrasound systems, transducers, and catheters in global markets (e.g., USA, EU, etc.).- Develop regulatory strategies for AI-enabled features and ensure compliance with emerging global regulations on Software/AI as a Medical Device.- Collaborate with R&D, Quality, and Clinical teams to integrate regulatory requirements throughout the product development lifecycle.- Prepare and compile high-quality regulatory submissions (e.g., Technical Documentation, 510(k), etc.).- Monitor and interpret evolving global regulatory requirements and communicate updates to internal teams.- Serve as liaison with international regulatory authorities or regional RA counterparts to address inquiries or deficiencies.- Support regulatory aspects of audits and inspections (e.g., ISO 13485, MDSAP, FDA, KGMP, etc.).- Contribute to risk assessments and design documentation reviews to ensure regulatory compliance.- Provide regulatory input to product lifecycle planning and change management processes.

공학계열, 의/약학계열,영어 (회화가능, 독해가능, 작문가능)