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- Homologation|Regulatory Certification Specialist
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.
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
- Attractive
Consultation
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- Investigation of laws and regulations related to technology development and product specifications, acquisition of certification, and external relations