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Business & corporate roles in Tokyo scored for foreign professionals — visa sponsorship, Japanese level, salary and fit. Create a matching profile to personalize the ranking.
Business & corporate roles in Tokyo scored for foreign professionals — visa sponsorship, Japanese level, salary and fit. Create a matching profile to personalize the ranking.
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Lead regulatory certification for close-range mobility products, preparing technical and risk documents, supporting QMS, reporting to authorities, and coordinating external laboratories.
Serve as a Regulatory Affairs and Certification Specialist for close-range mobility products and services being deployed globally. Lead preparation of technical documentation, support QMS at domestic and international facilities (FDA/CE/NMPA), create and maintain risk-management files, make regulatory reports as necessary, and coordinate with external test laboratories.
Required qualifications include understanding ISO 13485 requirements and experience responding to external audits; understanding ISO 14971 requirements and the ability to prepare risk-management documentation; and experience in product development, product commercialization processes, or regulatory affairs in the medical-device, mobility, robotics, or related industries. Business-level Japanese and English are required.
Preferred qualifications include MDSAP knowledge and audit experience; knowledge of software, cybersecurity, functional-safety, environmental, biological-safety, electrical-safety, EMC, RF testing, and medical-device regulations, along with related technical-documentation, test-planning, or coordination experience. The position is based at the head office in Higashi-Shinagawa, Tokyo.
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About WHILL
WHILL is a Japanese mobility company that designs and manufactures stylish personal electric wheelchairs and autonomous mobility services.
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