Regulatory Specialist(Sr.) (RE-33931671)

Location: Tokyo, Japan
Salary: competitive
Job Type: Permanent
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<About This Position>

The position is a Regulatory Affairs Specialist or Senior specialist based in Tokyo office. The (senior) Specialist is responsible for regulatory work depending on the company regulatory strategy. Main responsibilities include preparation of submission documents for regulatory approval and the maintenance for approved products.

<About the Company>

Leading global medical device company that develops innovative technology, tools and treatment options to help people worldwide

<Core Responsibilities>

  • Create necessary documentations for product submission in Japan market and conduct maintenance work such as submission of minor change notifications, partial change as needed
  • Communicate and/or negotiate with PMDA to obtain regulatory approval for vascular, structural heart, and other cardiovascular devices
  • Contribute to defining regulatory strategies for assigned products
  • Assess product, manufacturing, etc. changes for regulatory impact
  • Communicate with each business unit RA and manufacturer on assigned products
  • Work in a team of 3-4 people

<Basic Qualification>

  • Communication and negotiation with overseas team members (English language) (e-mail, telephone conference)
  • University Degree in Science or related fields
  • Class 3-4 regulatory work experience of medical device. (Preferably with cardiovascular devices)
  • Submission of PMDA applications for new products, partial changes, and minor change notifications. (Preferred experience in cardiovascular products)

Real is part of the larger SThree K.K group

To find out more about Real, please visit | Real についてもっと詳しく知りたい方はこちらへ→

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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