【Company summary/Why work here】
- 60 staff organization in Japan with over 30+ years in Japan (American company bought Japanese business to start operations in Japan; hence the company’s culture is balanced Japanese and American)
- Stable company with very low employee turn-over in Japan and globally.
- Good work life balance, FLEX work system, work from home and quite easy working environment (fairly slow pace).
- Strong recent growth of their key products business in Japan and generally stable business overall.
- Chance to work with global counterparts in the US mainly in English
- Opportunity to be involved in CE Mark, familiarize with European regulations and support new products regulatory approvals planned for the Japanese office.
- Salary negotiable (JPY 10M+)
A candidate as a manager position will maintain and improve safety management process and post-marketing process and lead them.
At the same time as doing activities in accordance with Japanese laws and regulations, the manager will work with the global and undertakes activities of the vision system based on European regulations and the manager will conduct and manage tasks of the safety management department prescribed by our company, such as updating CER, LSR following to MEDDEV 2.7.1.
・Maintain and improve safety management process (GVP) and post-marketing process(GPSP)
・Deal with European regulations (MEDDEV2.7.1/MEDDEV2.12-1)
・Deal with Japan complaints
・Work with the U.S headquarters and EU regal agent
・Report to government offices and meet with them including defect report etc.
・Response examinations for government offices and certification entities
・Ethical guidelines and related notices, clinical research method
・ISO14971, MEDDEV2.7.1, MEDDEV2.12-1
・At least About 5 years working experience and about 3 years in managerial position in Product Surveillance or related department
・Safety Manager’s role
・About 3 years GVP management
・Business level English is must.
・MS-Office(Excel, Word, Power Point)
・ISO13485、MDD／MDR is preferable but not must
・Compliance with regulations and quality are always top priority with the business thinking
・Bachelor’s degree preferably in Science