JOB ID 23179

Homologation|Regulatory Certification Specialist

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

In the field of short-range mobility, it is a company that continues to grow with a unique business model that combines hardware and services.
The introduction of transportation services using autonomous driving technology is steadily expanding both domestically and internationally, as they are being introduced to airports and large commercial facilities.
In addition, we are also providing mobility that can be operated by individuals for tourist attractions and outdoor facilities, expanding the range of usage scenarios.
In addition to online channels, we are also expanding our distribution network by strengthening partner collaboration.
In recent years, the number of introductions in overseas markets has increased, increasing our global presence.
It is attractive that we are promoting the construction of new mobility infrastructure while achieving continuous growth in both product and service axes.

As a legal certification specialist, you will be in charge of related tasks to accelerate the deployment of short-distance mobility products and services around the world.

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Job Description

  • Responsibilities
    ・Lead in the preparation of technical documents (software, cybersecurity, robotics, etc., and other general fields)
    ・QMS support for domestic and overseas facilities (FDA/CE/NMPA)
    ・Preparation and maintenance
    of risk management files ・Administrative reports for each country (as necessary)
    ・Negotiation
    with external laboratories ・Language skills: Business level in both Japanese and English
  • Requirements
    ・Understanding of ISO 13485 requirements and ability
    to respond to external audits, technical documentation skills
    , and experience involved in the commercialization process in the industries listed above (medical devices, mobility, robotics, etc.)
  • Preferred
    ・Knowledge and audit experience
    of the MDSAP system of quality management systems ・Knowledge of software, cybersecurity, functional safety, and robotics standards and documentation ability
  • 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, Weekends and holidays off, Make use of languages, Venture Company, New businesses and services

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【Recruitment Background】
As the world shifts towards carbon neutrality and digitalization, the creation of new laws and regulations to respond to this is becoming more active in countries around the world, and these laws and regulations greatly affect business strategies and often become technology development goals.
In order to achieve both the realization of an environmental and safe society and our business, we are strengthening our external relations activities that take the lead in laws and regulations, as well as legal compliance and certification support, and we are looking for people who can play an active role in this field.

【Duties】
In order to improve the legal compliance and competitiveness of products, we are in charge of responding to compliance with laws and regulations in each country, lobbying regulatory authorities (external relations), sharing information with planning, design, and sales departments, and obtaining certifications.

Details.

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