Regulatory Affairs Specialist (RE-33926769)

Location: Tokyo, Japan
Salary: ¥7000000 - ¥9000000 per annum + competitive
Job Type: Permanent
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<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.

<About the Company>

American based fast-growing and award-winning international medical technology and device company with operations spanning the globe. The company develops innovative, noninvasive monitoring technologies that save, extend and improve the lives of people of all ages, in all walks of life. By developing revolutionary technologies, the company helps to solve "unsolvable" problems that have plagued the healthcare industry.

<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

<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

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

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