#185 QA Regulatory Affairs Analyst
The company researches and develops Analytical medical products, mainly automatic blood analyzers that simplify, automate, and innovate complex biomedical testing. Their main industries are Diagnostics and Life Sciences. With a history of more than 80 years the company helps healthcare and laboratory professionals, pharmaceutical and biotechnology companies, universities, medical schools, and research institutions worldwide.
The headquarter is in the US and the development base is located in Shizuoka, Japan. The company has been expending the business in more than 180 countries, so you can work with members and customers from around the world.
Legal compliance business for blood analyzers and peripherals
・ Understand trends in the laws and regulations and communicate with related departments (R&D department, production technology department, etc.)
・ Overseas product registration (new, update, change) support.
This job role will be linked with other departments (R&D, marketing, etc.) and overseas offices.
Conferences with foreign countries are done with mainly conference calls.
・ Ability to understand related laws and regulations and develop into the business
・ Working experience using English (Speaking, Reading, Writing)
・ Business Japanese level
・ 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 regulations (RoHS, REACH, etc.)
・ Medical device design and development or QA-related work experience
・ Experience in compliance with regulations regarding the export of own products
Expected annual salary: ¥4M - ¥7.5M
Annual salary promotion: once a year (April)
Bonus: Incentive bonus is provided in March based on company performance and individual performance
Working location: Mishima, Shizuoka
Commuting allowance full payment up to 100,000 yen per month
Working hours: 8:45-17:00 (breaks: 12:15-13:00) 7.5 hours of actual work
Flextime system (core time 11: 00-15: 00)
Holiday:124 days in a year
Paid leave (given the number of days based on the company policy)
Trial period: 3 months (no change on the condition during the trial period)