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- Homologation|Regulatory Certification Specialist
JOB ID 23179
Homologation|Regulatory Certification Specialist
- Manufacturer, Manufacturer-Automotive
- Aftersales, Regulation＆Homologation
- Tokyo
- ¥5,000,000～¥7,500,000
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
- [Required Skills]
・Understanding of ISO 13485 requirements and experience
in handling external audits ・Understanding of ISO 14971 requirements and risk management Document preparation
skills ・Preferred skills: Knowledge and practical experience
in any field ・Product development and commercialization processes in industries such as medical devices, mobility, robotics, etc., ・Experience as a RA
[Required Languages Levels]
・Japanese (business level)
・Business-level or higher English conversational skills and English documentation skills
-
- Preferred
- [Preferred Skills]
・Knowledge of Quality Management Systems (MDSAP) and audit experience
・Knowledge of electrical safety, EMC, and RF testing such as IEC 60601-1 and IEC 60601-1-2, as well as experience
in negotiating and arranging test planning and testing organizations ・Experience
in entering regulatory requirements for product labels, instruction manuals, and package inserts ・Knowledge of medical device regulations such as FDA 510(k) and EU MDR, and experience
preparing technical documentation (such as Technical Documentation 510(k)) [Desired Candidate Profile]
・Empathy
for our mission and values ・Communication skills
in a global environment ・Those who can
grasp things in the context of the overall picture ・Those who can
concisely summarize key points and communicate them to others ・Those with
listening skills ・Those who can
persistently approach matters ・Those with a proactive attitude toward learning
-
- Location
- Tokyo
-
- Work Style
- Remote working possible, Flex working possible
-
- Salary
- ¥5,000,000～¥7,500,000
-
- 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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