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Location | Tokyo - 23 Wards |
Job Type | Permanent Full-time |
Salary | Negotiable, based on experience |
従業員満足度が高く、離職率が低い会社でQA/安全管理の経験を活かしませんか?
世界的な外資系医療機器メーカーにて、安全管理のシニアスペシャリストを募集しています。日本国内における製品安全性コンプライアンスおよび市販後監視活動を管理するポジションです。医療機器および医薬品関連規制への遵守を確保し、安全性情報の報告を担当、さらに社内チーム、製造業者、規制当局との間の重要なコミュニケーションハブとなる役割を担います。
主な職務内容
A global leader in medical device innovation is seeking a Senior Specialist in Safety Vigilance to manage product safety compliance and post-market surveillance activities in Japan. This critical role ensures adherence to medical device and pharmaceutical regulations, coordinates safety reporting, and serves as the communication bridge between internal teams, manufacturers, and regulatory authorities. Your contributions will directly impact patient safety and regulatory excellence.
Ensure compliance with relevant laws and safety regulations for medical devices and pharmaceuticals
Report adverse events and safety information to regulatory bodies accurately and within required timelines
Manage product complaints and investigations with external manufacturers
Track and process safety-related information using internal databases and tools
Collaborate with internal stakeholders to address customer concerns and align project workflows
Lead effective cross-functional communication to streamline issue resolution and reporting
Handle communication with regulatory authorities and industry stakeholders to ensure regulatory alignment
Minimum Experience Level | Over 3 years |
Career Level | Mid Career |
Minimum English Level | Business Level |
Minimum Japanese Level | Fluent |
Minimum Education Level | Bachelor's Degree |
Visa Status | Permission to work in Japan required |
必須条件
知識・経験:
ソフトスキル:
語学力
Minimum 3 years of experience in quality assurance or safety vigilance in the medical device or pharmaceutical industry
Deep knowledge of GVP, QMS, and local regulatory frameworks for post-market safety
Strong communication and business writing skills in both Japanese and English
Proficient in Microsoft Excel, including VLOOKUP and pivot tables
Ability to learn and adapt to internal tools and safety data systems
Excellent cross-functional coordination and stakeholder engagement skills
Japanese: Native
English: Business level
Experience working with global teams and manufacturers
Prior experience in managing audits or responding to health authority inquiries
Work for a global leader in medical device innovation
Collaborate with regional and international safety and QA teams
Gain high visibility in regulatory operations with direct patient impact
Enjoy remote work, flex time, and structured global benefits
Be part of a mission-driven team focused on regulatory excellence and safety
Job Type | Permanent Full-time |
Salary | Negotiable, based on experience |
Industry | Bank, Trust Bank |