RA Specialist/Manager (RE-33928390)

Location: Tokyo, Japan
Salary: ¥9000000 - ¥12000000 per annum + competitive
Job Type: Permanent
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<About the Position>

The focus is to complete and maintain regulatory approvals and clearances of assigned products.

<About the Company>

The global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company put helping patients into its life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, the company focuses on helping patients regain and improve the quality of their life.

<Key Responsibilities>

  • 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

<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 Ⅲ 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

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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