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Regulatory Affairs Manager (Medical Devices) 医療機器の法規制マネージャー

Job Details

Location: Japan
Salary: Negotiable
Job Type: Permanent
Specialization: Pharmaceutical & Medical Device, Legal & Compliance
Reference: BBBH48311_1714638759
No consultant assigned to this job.

Regulatory Affairs Manager (Medical Devices) 医療機器の法規制マネージャー

Our client are a medical device manufacturer, searching for a RA Manager.

Our client has a late retirement age and welcomes applications from senior applicants.


  • 医療機器の規制遵守業務を管理
  • 新製品の市場承認に向けた規制申請を調整
  • 各チームと連携し、規制戦略の計画及び実施を担当
  • 市販後監視とバジランス報告の監督


  • 医療機器業界での規制業務経験5年以上
  • 国内外の医療機器規制要件に関する幅広い知識
  • 複数プロジェクトの管理と納期の遵守に関する確かな経験


・ Manage regulatory compliance for medical devices
・ Coordinate regulatory submissions for market approval of new products
・ Collaborate with various teams to plan and implement regulatory strategies
・ Oversee post-market surveillance and vigilance reporting


・ At least 5 years of experience in regulatory affairs within the medical device industry
・ Thorough knowledge of global regulatory requirements for medical devices
・ Proven ability of managing multiple projects and deadlines

Expired Job

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Expired job

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