[medtech] 薬事本部 Bura Orthopaedics 薬事リーダー

J&J FAMILY OF COMPANIES

Chiyoda, Tokyo, Japan
5+ years medical device regulatory experience
Class ii or higher medical device expertise
English reading and communication skills
The role involves planning and executing regulatory actions to support business goals within the Orthopaedics division

Job Summary

  • The role involves planning and executing regulatory actions to support business goals within the Orthopaedics division.
  • Candidates must be able to read English design documents from overseas manufacturers and communicate effectively with international stakeholders.
  • This position will transition to become an employee of DePuy Synthes following the planned separation of Johnson & Johnson's Orthopaedics business.

Matching Summary

The role involves planning and executing regulatory actions to support business goals within the Orthopaedics division.

Skills & Requirements

Must-have

  • 5+ years medical device regulatory experience
  • Class II or higher medical device expertise
  • English reading and communication skills
  • PMDA submission and negotiation experience
  • Post-market change management procedures

Nice-to-have

  • Led PMDA pre-submission consultation meetings
  • Experience mentoring team members in RA
  • Master's degree in science or medicine fields
  • Supporting business strategy alignment

Key Requirements

  • Minimum 5 years medical device regulatory affairs experience
  • Class II or higher medical device background required
  • Advanced English proficiency for technical documentation
  • Master's degree preferred in engineering, pharmacy, or life sciences

Work Rights

Not specified

Tailored Resume

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