募集要項
- 募集背景
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<About this Role>
This role's primary mission is to accelerate products' approval for Japanese Market by working as project's member. Depends on the person's skill, experience and motivation, the position might lead the project. The primary mission includes work based on required knowledge on Japanese regulation including Clinical affairs and Quality management area that are necessary for product submission. Also, the person might work with external experts for Pre-approval clinical trial for regulatory or PMS purpose when necessary.
- 仕事内容
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RA Specialist<Main Responsibilities>
* Contribute to establishing and maintaining effective project management system to accelerate product approval.
* Develop effective regulatory strategy for each project and achieve active product introduction.
* Enhance internal compliance and risk management system based on understanding of the Japanese PMD Act and other business-related laws and regulations.
* Prepare and submit approval, certification, and the notification of medical device applications/Maintain registrations (license of Foreign Manufacturer registration, business license)
* Support in license renewal projects
* Maintain and develop relationships with regional colleagues, business partners, industry associates, regional regulatory bodies, and medical society.
* Motivated to learn other areas that are related to RA such as reimbursement or Clinical work. The person will be requested to learn about these areas according to company situation and discussion to set personal development goal.
* Enough knowledge about QMS for RA product submission, QMS inspection and reliability inspection. (Minimum requirement)
* Motivated to lean about QMS to establish/improve Quality Management System.
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
- To accelerate products' approval for Japanese Market by working as project's member.
- 歓迎
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*Willingness to manage long-term project or team project, and to challenge on complicated situation/subjects.
*Experience in establishing/improving Quality Management System (can be partially).
*Bachler degree of science (pharmacy, engineering, and others)
*Business level English in verbal communication
- フィットする人物像
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<Qualifications>
<Minimum>
* Bachelor's Degree
* 5 years or more experience in RA working with Medical Device in Japan (product registration for class III or IV preferred)
* Knowledge on Japanese Pharmaceutical and Medical Device Law/Regulation and product submission process
* Native level Japanese proficiency
* Business level English (writing and reading)
* Smooth operation of MS Word, PowerPoint, Excel, and Visio (+Photoshop, preferred)
* Overseas business trips (0-2/year) and domestic business trips (0-10/year)
<Preferred>
* Willingness to manage long-term project or team project, and to challenge on complicated situation/subjects.
* Experience in establishing/improving Quality Management System (can be partially).
* Bachler degree of science (pharmacy, engineering, and others)
* Business level English in verbal communication
- 雇用形態
- Permanent
- 勤務地
- Tokyo
- 年収・給与
- JPY7,000,000.00 - JPY9,000,000.00 per annum + competitive
