Job Types
Quality Assurance, Regulatory Affairs, Clinical Planning, and Scientific Affairs
Job Overview
We are involved in academic research and the design and development of instruments and reagents. We also handle regulatory applications to each countries' 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.
- Review the product design process and respond appropriately if defects are detected.
- Conduct QA audits of domestic and overseas manufacturing factories and suppliers.
- Oversee the quality control process of products at factories and determine market release.
- Prepare academic materials for publication, academic research, presentations at academic conferences.
* Submit applications for regulatory approval for pharmaceuticals, medical devices, etc. to regulatory authorities around the world for sale and approval of use. (In Japan, the regulatory authority is the Ministry of Health, Labor, and Welfare.)
* 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.
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.