[Kyoto]Regulatory Affairs Specialist for Development

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ARKRAY is a Japanese global healthcare company that can provide everything from development, production, sales and marketing to customer services for medical devices, in-vitro diagnostics products, and more.
In particular, our company is known as a leading company within the diabetes testing field. Our accumulated technical know-how allows us to contribute in not only the diabetes testing field, but also in other testing fields.
Our technical prowess and products have received high evaluations from specialists all over the world.

In order to achieve our group mission, “To contribute to the health and well-being of people all over the world through the advancement of science and the discovery of new technologies”, we have been delivering new medical technologies and products to medical facilities.

We are currently seeking for a Regulatory position who will be responsible for regulatory submissions related to the sale of medical devices and in-vitro diagnostics overseas.

▍Job Description.
・In order to market medical devices and in-vitro diagnostics in foreign countries, the laws
and regulations of the countries in which they are sold must be followed.
・Preparation and submission of materials to demonstrate the effectiveness and safety of the products is required in order to obtain marketing authorization from each country's government. 
・In cooperation with members of the Research and Development (R&D) Divisions and overseas offices, hold regulatory strategy meetings to determine what explanations will be given to obtain this marketing authorization in accordance with the laws and regulations of each market (mainly Japan, United States and Europe).
・Prepare related materials (including translation of R&D materials from Japanese to English, and vice-versa). 
・Communicate with R&D staff in Japanese and with overseas office members in English.
・Interpretation will also be required at meetings.

Employment Type: Full-time (Permanent)

Expected Annual Salary: ¥4,100,000 – ¥6,400,000

Work Location: Kamigyo-ku, Kyoto City (Kyoto Research Center)

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Requirement;

MUST;
Native or Business English level (e.g. TOEIC 800+) and Native Japanese level (e.g. N1 of the Japanese Language Proficiency Test)

Prefer;

• Experience working in the healthcare manufacturing industry.
• Logical thinking skill
• Date analysis skill
• Science knowledge (graduate from science high school/university)