JOB ID 28180

Senior Regulatory & Homologation Specialist

  • Manufacturer, Manufacturer-Automotive
  • Aftersales, Regulation&Homologation
  • Tokyo
  • ¥6,000,000~¥10,000,000

In the short-distance mobility sector, we continue to grow with a unique business model that combines hardware and services.
Introductions to airports and large commercial facilities are progressing both domestically and internationally, and the implementation of mobility services utilizing autonomous driving technology is steadily expanding.
Additionally, we are providing mobility devices that can be operated by individuals for tourist destinations and outdoor facilities, broadening the range of usage scenarios.
In aircraft sales, we are expanding our distribution network by strengthening partnerships in addition to online channels.
In recent years, our track record of introductions in overseas markets has increased, enhancing our global presence.
Our attractive point is that we are promoting the construction of new mobility infrastructure while achieving continuous growth on both product and service axes.

As a regulatory certification specialist, you will be responsible for the following tasks to accelerate the global deployment of short-distance mobility products and services.

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Job Description

  • Responsibilities
    ・Lead
    the preparation of technical documents ・QMS support for domestic and overseas facilities (FDA/CE/NMPA)
    ・prepare and maintain
    risk management files ・Administrative reports from each country (as needed)
    ・Negotiate with external testing laboratories
  • Requirements
    ・Understanding of ISO 13485 requirements and experience
    in external audit responses ・Understanding of ISO 14971 requirements and risk management Document preparation
    skills ・Product development and commercialization processes in industries such as medical devices, mobility, robotics, and other industries ・Experience as a RA
    ・Preferred skills: Knowledge and practical experience
    in any of these fields ・Language proficiency (business-level in both English and Japanese)
  • Preferred
    ・Knowledge of and audit experience with quality management systems (MDSAP)
    ・Knowledge of software, cybersecurity, and functional safety standards such as IEC 62304, IEC 81001-5-1, and IEC 61508, as well as the ability to prepare technical documents
    ・Knowledge of RoHS, REACH, and biological safety assessments (ISO 10993 series, etc.), as well as the ability to prepare technical documents
    ・Knowledge of electrical safety, EMC, and RF testing standards such as IEC 60601-1 and IEC 60601-1-2, as well as experience in test planning, negotiating with testing organizations, and coordinating test arrangements
    ・Knowledge of medical device regulations (such as FDA 510(k) and EU MDR), and experience preparing technical documentation (Technical Documentation, 510(k), etc.)

    [Desired Qualities]
    ・Alignment with our company’s Mission and Values
    ・Communication skills in a global environment
    ・Ability to view matters within the broader context
    ・Ability to concisely summarize key points and convey them to others
    ・Strong listening skills
    ・Perseverance in tackling tasks
    ・Proactive attitude toward learning
  • Location
    Tokyo
  • Work Style
    Remote working possible, Flex working possible
  • Salary
    ¥6,000,000~¥10,000,000
  • Attractive
    Points
    Secondary JOB possible, Japanese company with global opportunities, Over 50% Mid-Career Hires, Make use of languages, Weekends and holidays off, Venture Company, New businesses and services

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