Specialist, RA

The Regulatory Affairs Specialist supports global regulatory compliance for in vitro diagnostic (IVD) products where the company acts as the Legal Manufacturer, ensuring timely market access and adherence to international standards.This role encompasses product registration, launch, change management, and other regulatory activities such as site registration, audit support, documentation control, and compliance with ISO 13485-based Quality Management System (QMS). The position requires close collaboration with internal teams and external stakeholders to maintain regulatory conformity and support global distribution.Prepare, submit, and track regulatory applications for product launches, market expansion, and registration renewals.Evaluate the regulatory impact of product changes and coordinate actions within change control processes.Ensure labeling compliance, including managing translations and verifying regulatory requirements.Support interactions with regulatory authorities and Notified Bodies, responding to inquiries and submitting required documentation.Assist with audits and inspections by providing regulatory documentation and responding to regulatory-related inquiries as a subject matter expert.Manage adverse event reporting and ensure timely communication with relevant departments.Monitor global regulatory changes and communicate updates with internal stakeholders.Maintain and update documentation required for product approvals and certifications.Conduct regulatory reviews within internal change control processes and collaborate with cross-functional teams.Strong English and Japanese communication skills (written and verbal)Experience in Regulatory Affairs for IVD or Medical Devices; typically 2+ years preferred, but equivalent experience consideredAbility to collaborate effectively with cross-functional teamsUnderstanding of regulatory requirements for IVD/Medical DevicesBasic understanding of ISO 13485 and global QMS principlesBachelor’s degree in Life Sciences, Engineering, or related field (preferred)High attention to detail and strong documentation management skillsExperience in building and maintaining Technical Files (e.g., IVDR, CSDT, STED)Hands-on experience with international product registrations and change submissionsProject coordination or cross-functional collaboration experienceFamiliarity with risk management principles (ISO 14971)Strong technical writing skills for regulatory documentationAbility to monitor and interpret global regulatory changes (Regulatory Intelligence)