Lead regulatory certification for close-range mobility products, preparing technical and risk documents, supporting QMS, reporting to authorities, and coordinating external laboratories.
About this role
This regulatory affairs and certification specialist joins WHILL’s five-person RA team, supporting personal mobility products and services as new consumer and autonomous-driving models are developed for international markets. The role spans regulatory affairs, quality management and product commercialization across medical-device, welfare-device and autonomous-mobility schemes.
Responsibilities include technical documentation, QMS activities for domestic and overseas facilities under FDA, CE and NMPA-related frameworks, preparation and maintenance of risk-management files, regulatory reporting when needed, and coordination with external testing laboratories.
Applicants must understand ISO 13485 requirements and have external-audit experience, understand ISO 14971 requirements, and prepare risk-management documents. Practical experience in product development, commercialization or regulatory affairs in medical devices, mobility or robotics is also required. Business-level Japanese, business-level-or-higher spoken English and English documentation skills are specified.
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