募集要項
- 募集背景
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This is a position responsible for regulatory submissions of our company's products and related regulatory affairs tasks.
- 仕事内容
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Job Description:
● Conduct regulatory affairs tasks for dental products (devices, dental materials, implants, etc.)
● As part of the regulatory affairs department, have awareness and understanding of the Pharmaceutical and Medical Device Act
● Obtain manufacturing and marketing approval/certification for medical devices (Class I-III), handle changes, and submit notifications
● Manage business operations under the Pharmaceutical and Medical Device Act, such as manufacturing site registration
● Prepare and submit insurance reimbursement application documents
Main Communication Partners:
● Headquarters (Europe/Americas): Design, Development, Quality Assurance, and Marketing department staff
● Company's Sales, Marketing, and Service department staff
- 応募資格
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- 必須
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Required Qualifications:
● Experience in regulatory affairs submissions for medical devices
● Business-level English communication skills for conversation, reading, and writing (conference calls with headquarters are conducted in English)
Preferred Qualifications:
● Experience in regulatory affairs submissions for dental products
● Experience in regulatory affairs submissions for implant products
- 雇用形態
- Full-Time/正社員
- ポジション・役割
- Regulatory Affairs Specialist
- 勤務地
- Tokyo
- 年収・給与
- 5 million yen ～ 7.49 million yen
