募集要項
- 仕事内容
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＜RA Principal Specialist＞Job Summary
Provide support on a range of medical device and activities which include product submissions, develop regulatory strategies, change assessments, commercial supports, compliance related activities, systems/process improvements and other responsibilities aligned with medical device regulation and business goals.
Keep the good relationship with related authorization agencies.
• Develop and implement regulatory strategy and suitable yearly plan to ensure the actual registration operation per set timeline for all types of product registrations (includes product with clinical data)
• Author product submission/notification, correspondent letter to authority
• Directly communicate with local authority (MHLW/PMDA) upon implementing regulatory strategy and correspondent on submissions.
• Monitor regulation, policy and standard changes from government authorities that have impact to company’s products.
• Assess regulatory impact on various product/process change
• Author reimbursement submission document
• Review and approve advertising/promotional material to assure compliance with governing advertising/promotion
• Collaborate with necessary internal/external source to proceed assigned projects
• Attend related industry meetings to gather latest information and input necessary company opinion with internal cross functional alignment
• Performs other duties as needed
- 応募資格
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- 必須
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Education & Experience
• Bachelor’s Degree in related field, Science background preferred
• 7+ years’ experience in medical device regulatory affairs including submission with clinical data
• Prior experience authoring and receiving approval of medical device SHONIN submission document with clinical data
• Prior experience on C1/C2 reimbursement submission preferred
Skills
• Comprehensive knowledge of current regulations and guidelines
• Fluent in Japanese/English reading, writing and communication
• Familiar with MS Office applications
• Strong project management skills
• Ability to adapt constant changes in fast pace
- 雇用形態
- 正社員
- 勤務地
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東京都／リモートワーク制度あり
- 勤務時間
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フレックス制度あり
- 年収・給与
- 900～1500万円（スキル・ご経験により決定）
