Job Types

Job Overview

We are involved in supporting the design and development of instruments and diagnostic reagents from a regulatory perspective. We are responsible for handling and submitting regulatory applications to regulatory authorities, such as the Ministry of Health, Labor, and Welfare.

Job Description

• Research product design processes from a regulatory perspective and share the information with others.
• Submit applications for regulatory approval to the Ministry of Health, Labor and Welfare, the FDA (US), etc.

* Regulatory approval applications: Submit applications for the approval of pharmaceuticals, medical devices, cosmetics, etc. to regulatory authorities around the world (in Japan, the Ministry of Health, Labor, and Welfare) to obtain approval for sale and use.

* This is a highly specialized position that conducts research activities to obtain approval and licenses from regulatory authorities in various countries in order for Sysmex products to be sold globally.

Expected Hiring Grade

• LG1 Leading, Base Salary: 270,000 yen

* Entry grade and base salary will be determined based on the candidate’s experience and expertise.

Potential Initial Assignment Location

• Technopark, Solution Center (Hyogo Prefecture)

* Proactive efforts underway to promote working remotely, SuperFlex

Recommended for:

• Individuals who wish to have a professional career in Quality Assurance, Regulatory Affairs, Clinical Planning, and Scientific Affairs in a global company.
• Individuals who want to gain a holistic view of the company by cooperating with many divisions and overseas affiliate companies.
• Individuals who want to make use of their pharmaceutical knowledge or qualifications.
• Individuals who want to make use of their clinical testing knowledge or qualifications as a medical technician.

Relevant Majors

Mechanical Engineering, Mathematics, Electrical and Electronic Engineering, Information Technology, Physics and Applied Physics, Biology and Life Sciences, Chemical and Materials Engineering, Natural Resources and Global Environment, Agriculture and Agricultural Sciences, Pharmaceutical Sciences (4-year course), Pharmaceutical Sciences (6-year course), Medicine and Dentistry, Veterinary Medicine, Hygiene and Medical Care, other Sciences.

Law and Policy Studies, Economics, Management and Commerce, Social and Environmental Information Studies, Foreign Languages and International Culture, Humanities, Education, Life Sciences, Medical and Health Sciences, other Humanities.