募集要項
- 募集背景
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<About the Position>
The focus is to complete and maintain regulatory approvals and clearances of assigned products.
- 仕事内容
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<About the Position><Key Responsibilities>
The focus is to complete and maintain regulatory approvals and clearances of assigned
products
* Prepare and oversee documentation packages for submission to Japan regulatory agencies. Track timelines and documents milestone achievements for inclusion in regulatory submissions. May interact with regulatory agencies as part of submission review and on-site audit support
* Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues; also keeps management apprised of alternative actions. Review and approve protocols, reports, engineering drawings, procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance, consistency, and accuracy
* Provide guidance on regulatory requirements necessary for strategic and contingency planning
* Monitor proposed and current global regulations and guidance; assess impact of such regulations and guidance on assigned project(s), propose suggestions on utilizing regulatory updates to expedite approval process
* Review promotional material and labeling content product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracy
Real is part of the larger SThree K.K group
To find out more about Real, please visit www.realstaffing.com | Real についてもっと詳しく知りたい方はこちらへ→ www.realstaffing.com
Award winner of:
Great Place to Work 2019 | Growth Company of the Year by TALint Recruitment Awards 2019 | Best Healthcare & Life Sciences Recruitment Company of the Year by Recruitment International Awards 2018
- 応募資格
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- 必須
- The focus is to complete and maintain regulatory approvals and clearances of assigned products
- 歓迎
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<Preferred Experience>
・Experience in preparing domestic and international product submissions
・Master's Degree or equivalent in related field(e.g. Pharmaceuticals)
- フィットする人物像
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<Education and Experience>
* Bachelor's Degree or equivalent in in related field or scientific discipline (e.g. Biology, Microbiology, Chemistry),
* 5 years RA(Class3 and/or 4 product) experience of previous related experience Required
<Preferred Experience>
* Experience in preparing domestic and international product submissions
* Master's Degree or equivalent in related field(e.g. Pharmaceuticals)
<Additional Skills>
* Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
* Excellent written and verbal communication skills including negotiating and relationship management skills
* Good ability to read and write English
* Full knowledge and understanding of Japan regulations relevant to medical devices(regulation requirements for new products, product changes, and new product development systems), Class 3 and/or Class IV devices
* Good leadership skills
* Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
* Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
* Native level Japanese
- 雇用形態
- Permanent
- 勤務地
- Tokyo
- 年収・給与
- JPY9,000,000.00 - JPY12,000,000.00 per annum + competitive
