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).
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 considered
Ability to collaborate effectively with cross-functional teams
Understanding of regulatory requirements for IVD/Medical Devices
Basic understanding of ISO 13485 and global QMS principles
Bachelor's degree in Life Sciences, Engineering, or related field (preferred)
High attention to detail and strong documentation management skills
Experience in building and maintaining Technical Files (e.g., IVDR, CSDT, STED)
Hands-on experience with international product registrations and change submissions
Project coordination or cross-functional collaboration experience
Familiarity with risk management principles (ISO 14971)
Strong technical writing skills for regulatory documentation
Ability to monitor and interpret global regulatory changes (Regulatory Intelligence)
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Matsudo Abbott ￥6,000,000 - ￥8,000,000 per yearThe Regulatory Affairs Specialist supports global regulatory compliance for in vitro diagnostic (IVD) products ensuring timely market access and adherence to international standards. · This role encompasses product registration launch change management and other regulatory activi ...
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