Regulatory Affairs Senior Specialist / Principal – 循環器医療機器

AbbVie

Tokyo, Japan
Not specified; not specified; not specified
Onsite
5+ years medical device regulatory experience
Class iii/iv medical device application expertise
Pmda submission document preparation
AbbVie is seeking a Regulatory Affairs Senior Specialist/Principal for its cardiovascular medical devices division in Tokyo, Japan. The ideal candidate will lead regulatory activities, focusing on high-risk Class IV medical devices, and must possess strong expertise and independence in navigating complex regulatory frameworks

Job Summary

  • This role leads regulatory affairs for Abbott Medical Japan's cardiovascular medical devices, primarily Class IV high-risk equipment.
  • The position requires leading product approvals, lifecycle management, and acting as a primary liaison with the PMDA and other stakeholders.
  • Candidates will work in a collaborative environment emphasizing face-to-face communication to ensure accuracy and speed in regulatory processes.

Matching Summary

Match Score: 85

AbbVie is seeking a Regulatory Affairs Senior Specialist/Principal for its cardiovascular medical devices division in Tokyo, Japan. The ideal candidate will lead regulatory activities, focusing on high-risk Class IV medical devices, and must possess strong expertise and independence in navigating complex regulatory frameworks.

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • 5+ years medical device regulatory experience
  • Class III/IV medical device application expertise
  • PMDA submission document preparation
  • English business communication proficiency
  • Stakeholder management and project leadership

Nice-to-have

  • Direct negotiation experience with regulatory authorities
  • Development of regulatory strategies
  • Handling complex or precedent-setting cases
  • Internal influence without formal management role

Key Requirements

  • Bachelor's degree or higher in science field
  • Minimum 5 years practical experience in medical device regulatory affairs
  • Proven experience creating submissions for Class III/IV devices
  • Ability to conduct business operations in English

Work Rights

Not specified

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