JOB DESCRIPTION

QA Analyst Regulatory Affairs Specialist for a Life Science Company

Finance, Law, HR, Back office

About
About the company
The company is an American company that makes biomedical laboratory instruments. It is a very global company that operates in more than 120 different countries worldwide. The company has successfully built a global reputation in different sectors, but they are mainly successful in three sectors: life science, clinical examination, and particle properties field.

In Japan, they have established their R&D laboratory which works mainly on automatic blood analytical equipment. The laboratory is located in the place where you can see Mt.Fuji right in fornt of you and the laboratory is located in the area where you can appreciate a lot of great natures.

In this company, you can work on R&D which can contribute to the improvement of people’s health status through providing innovative healthcare products.
Corporate Culture
Unlike many other foreign firms, its R&D laboratory is located in Japan which makes Japan as very unique position among many other global offices. The company is located in rather country side, so everybody commutes using cars. The place is perfect for those who loves to focus on research and development. There are more than 150 researchers working in the laboratory. The company has flat work environment that you do not need to feel pressured to stay in the office until your boss leaves. Average daily work hours is about 7 hours and half.
Experts in different fields gather at one place and pursue a project.
Global Aspects
  • Deal with global projects
  • Already foreign employee(s) working
  • Joint company/office overseas
  • International sales
PR Aspects
The company works on collaboration of research with other global offices, so it requires all the researchers to have regular communications with foreign offices. Also there are frequent business trips abroad. Although it is a foreign firm and there are many global aspects in their work, the number of foreign employees is still limited, but they are considering to work hard on having more cultural diversity.
JobDescription
You will be responsible for legal compliance of blood analyzers and peripheral equipment.

Key Responsibilities:
・Understanding trends in laws and regulations and expanding to related departments (R&D department, production technology department, etc.).
・Overseas product registration (new, update, change) support.
・Collaboration with other departments (R&D, marketing, etc.) and overseas offices.
・Teleconference with overseas networks.

※Please note that the position is only for those who are currently residing in Japan only
Requirements
Must
-Ability to understand related laws and regulations and develop into business.
-Business level English skills (Speaking, Reading, Writing).
-College graduate or higher.
Japanese Level
  • Intermediate
Better
-Experience registering overseas products for medical devices.
-Work experience in medical equipment, pharmaceuticals, in-vitro diagnostic equipment.
-Experience with other overseas regulations and standards.
-Experience responding to environmental laws and regulations (RoHS, REACH, etc.).
-Project member experience.
-Medical device design and development or quality related work experience.
-Experience in compliance with regulations regarding export of own products.
Type of people (Personality)
-Person who can enjoy communication with overseas offices.
-Person who can communicate voluntarily to solve problem.
Conditions
Annual Expected salary (Minimum)
4000000
Annual Expected salary (Maximum)
7500000
Salary promotion
Once a year(April)
Transporation cost coverage
  • Fully covered
Work hours
8:45 - 17:00
Flextime
  • Yes
Holidays
  • End of Year and New Year Holiday
  • Saturday
  • National Holiday
  • Sunday
Insurances
  • Worker’s Accident Compensation Insurance (労災保険)
  • Health Insurance (健康保険)
  • Unemployment Insurance (雇用保険)
  • Welfare Pension Insurance (厚生年金保険)
-Bonus: Once a year
-Corre time: 11:00~15:00
-Holiday: 125 days (in 2020)
-Overtime work: average: 30 hours