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Job Types > Regulatory Affairs and Quality Control

Regulatory Affairs and Quality Control

Job Overview

We provide quality assurance for instruments and reagents from design and development to sales and service. We also handle applications to gain pharmaceutical approval from the Ministry of Health, Labour and Welfare.

Job Description

  • Review product design processes and integrate response in the event of defects
  • Carry out quality audits of domestic and overseas manufacturing plants and suppliers
  • Carry out quality control of factory products and determine whether they can be shipped to the market
  • Draw up applications for regulatory approval to the Ministry of Health, Labour and Welfare, the FDA (US), etc.

* We are responsible for obtaining regulatory approval for Sysmex products to be sold globally, and for also ensuring a continued supply of products that maintain the approved performance and safety levels.

Potential assignments

  • Quality Assurance & Regulatory Affairs Division

Recommended for:

  • Individuals who wish to have a professional career in quality assurance and regulatory 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 as a pharmacist

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