【医療機器審査員】【薬機法担当】- Japanese Required, Homebased

BSI Group

Tokyo, , Japan
Quality management system evaluation
Medical device regulatory assessment
Client relationship management
The Client Manager acts as the face of BSI, working closely with customers primarily in the Asia Pacific region to evaluate quality management systems against legal and regulatory requirements

Job Summary

  • The Client Manager acts as the face of BSI, working closely with customers primarily in the Asia Pacific region to evaluate quality management systems against legal and regulatory requirements.
  • This role involves conducting audits, preparing reports, and recommending certifications such as ISO 13485, ISO 9001, CE, and MDSAP to support client performance improvement.
  • BSI promotes diversity and equal opportunity, encouraging collaboration and continuous improvement within its delivery teams to uphold client-first 'Assessor Excellence' standards.

Matching Summary

The Client Manager acts as the face of BSI, working closely with customers primarily in the Asia Pacific region to evaluate quality management systems against legal and regulatory requirements.

Skills & Requirements

Must-have

  • Quality management system evaluation
  • Medical device regulatory assessment
  • Client relationship management
  • Audit report preparation
  • Frequent business travel
  • Japanese language proficiency
  • Business English communication

Nice-to-have

  • Team leadership and coaching
  • Commercial acumen
  • Problem-solving under pressure
  • Continuous professional development
  • Ethical and professional conduct

Key Requirements

  • 4+ years full-time medical device industry experience
  • 2+ years experience in R&D, manufacturing, clinical trials, or regulatory services
  • Degree related to medical devices or relevant scientific/engineering fields
  • Business-level Japanese and English proficiency
  • Ability to travel frequently for client visits

Work Rights

Not specified

Tailored Resume

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