Sr. Associate Specialist, Regulatory Affairs

Sr. Associate Specialist, Regulatory Affairs in Japan (Hino) focuses on regulatory activities for Class II active medical devices. Under guidance from supervisor or project lead, this role provides regulatory input to ensure product development aligns with target market regulatory requirements, prepares and submits regulatory applications to authorities, and collaborates cross-functionally with R&D, QA, Safety, and Global RA. Responsibilities include regulatory strategy development, lifecycle management, post-market compliance, handling authority inspections, reviewing promotional materials for regulatory alignment, and contributing to technical documentation. Requires advanced Japanese regulatory documentation skills, business-level English, and ~3 years of regulatory affairs experience with ability to communicate effectively with authorities. Opportunities to work with global teams, engage in remote-capable work, and contribute to introducing new devices to the Japanese market. GE HealthCare is an Equal Opportunity Employer, committed to inclusion and integrity.