Director of Regulatory Affairs

Company Description Barreleye is a global leader in quantitative ultrasound solutions, specializing in using artificial intelligence to analyze ultrasound signals and quantify cellular characteristics. Their innovative technologies deliver diagnostic assistance in real-time tissue and biomechanical analysis, focusing on applications like breast cancer detection, fatty liver diagnosis, and cardiac function assessment. With a mission to set new standards in medical services, Barreleye aims to make high-quality healthcare accessible to everyone. Their cutting-edge solutions, such as Int-BUS and Vis-CUS, provide precise, accurate, and consistent results, contributing significantly to early diagnosis and improved healthcare outcomes. Role Description This is a full-time, on-site role for a Director of Regulatory Affairs based in Seoul, South Korea. The Director of Regulatory Affairs will oversee the development and implementation of regulatory strategies, ensuring compliance with relevant laws and industry standards. Responsibilities include managing regulatory submissions, collaborating with cross-functional teams, and maintaining up-to-date knowledge of regulatory requirements. The individual will play a crucial role in supporting the company’s mission to deliver innovative medical technology solutions while ensuring adherence to regulatory frameworks. Qualifications Strong knowledge of Regulatory Requirements and experience in developing and maintaining compliance with applicable laws and standardsExpertise in Regulatory Strategy and creating effective pathways for the approval of medical devicesProven experience in Regulatory Affairs, including handling approvals, audits, and certificationsHands-on experience with submitting and managing Regulatory Submissions to relevant authoritiesAbility to lead Cross-functional Team collaborations and effectively communicate across departmentsExcellent leadership, analytical, and organizational skillsMaster’s degree in Regulatory Affairs, Life Sciences, or a related field; a relevant certification (e.g., RAC) is a plusExperience in the medical device industry and familiarity with AI-based diagnostic solutions is strongly preferred