募集要項
- 募集背景
-
<About the Position>
In this role, the person will be an integral part of an expanding regulatory affairs team that is responsible for maintaining and documenting the company's mission critical Japanese regulatory filings and registrations. The person's medical device regulatory expertise, organizational ability, and multi-tasking skills will be rewarded with opportunities for career growth and advancement in a company that makes a difference in people's lives.
- 仕事内容
-
Regulatory Specialist / Sr. Regulatory Specialist (Japan)<Duties and Responsibilities>
* Prepare and submit approval, certification and the notification of medical device applications/Maintain registrations
* Prepare and coordinate successful regulatory strategies for medical devices that ensure timely regulatory clearances
* Communicate with international RA and Engineering groups for getting necessary information
* Interact with regulatory bodies such as MHLW/PMDA
* Work with certified labs on product certification testing
* Maintain and submit Japan RA status report to International RA on a biweekly or as needed basis Provide guidance to other departments on Japanese regulatory requirements
* Provide regulatory support to the OEM development group
* Maintain up-to-date knowledge on Japanese regulatory requirements
* Available to travel to US headquarters at least once a year
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
-
- 必須
- Regulatory Specialist / Sr. Regulatory Specialist (Japan)
- 歓迎
-
* Experience interacting with regulatory bodies such as MHLW/PMDA and the Notified Body
* Experience working for a foreign medical device company
* Willing to travel to US headquarters on a quarterly basis or as needed
- フィットする人物像
-
<Required Education/Skills>
* BA/BS Degree or equivalent
* RA experience in medical device company, especially approval or certification of submission.
* Fluent Japanese speaking and reading ability
* English speaking and reading ability
* Knowledge on regulatory submission requirements for Japanese approval, certification and the notification of medical device applications.
* Excellent prioritizing, organizational, collaborative and interpersonal skills
* Computer Proficiency with MS Office (Word/Excel/Outlook)
<Preferred Education/Skills>
* Experience interacting with regulatory bodies such as MHLW/PMDA and the Notified Body
* Experience working for a foreign medical device company
* Willing to travel to US headquarters on a quarterly basis or as needed
- 雇用形態
- Permanent
- 勤務地
- Tokyo
- 年収・給与
- JPY7,000,000.00 - JPY9,000,000.00 per annum + competitive
