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Location | Tokyo - 23 Wards |
Job Type | Permanent Full-time |
Salary | Negotiable, based on experience |
経験3年目安・リモートワーク・オプションあり!
世界的なライフサイエンス企業のQA担当として、医療機器および診断機器に関する市販後安全性管理および規制コンプライアンス対応をリードしていただきます。製品の安全性維持、品質基準の遵守、社内外ステークホルダーへの効果的な情報提供・品質システム管理を通じて、組織全体をサポートする重要な役割を担います。APACとの連携など、国際的な業務にも携われます。
A global life sciences company is seeking a Quality Management Specialist to oversee post-market safety and regulatory compliance for medical and diagnostic devices. This role plays a critical part in maintaining quality standards, ensuring product safety, and supporting internal and external stakeholders through effective communication and quality systems management. You will help shape regulatory strategies and uphold compliance across APAC operations.
Manage post-market safety activities for diagnostic and medical devices in accordance with regulatory guidelines
Communicate safety measures and regulatory updates to internal teams and external partners
Handle customer complaints and quality issues, working closely with manufacturers
Develop and maintain quality systems that align with QMS and internal protocols
Monitor and report regulatory compliance across product lines and operations
Partner with cross-functional teams to investigate safety concerns and ensure ongoing regulatory conformity
Ensure compliance with chemical, environmental, and product safety regulations
Minimum Experience Level | Over 3 years |
Career Level | Mid Career |
Minimum English Level | Daily Conversation |
Minimum Japanese Level | Fluent |
Minimum Education Level | Bachelor's Degree |
Visa Status | Permission to work in Japan required |
必須条件
経験・知識:
ソフトスキル:
語学力:
At least 3 years of experience in quality assurance, safety management, or regulatory affairs within the medical device or diagnostics industry
Background in product development, design, or manufacturing processes
Familiarity with QMS (Quality Management Systems), GVP, and other medical device regulations
Bachelor's degree in chemistry, biology, pharmacology, engineering, or a related field
Strong ability to structure technical content and prepare clear documentation
Excellent self-management skills with the ability to take initiative and drive progress
Business-level proficiency in English and native-level Japanese
Japanese: Native
English: Business level
Experience with regulatory inspections or audits
Familiarity with global compliance standards and safety protocols
Join a market-leading life sciences company with a global reputation
Gain exposure to international QA and regulatory operations
Collaborate with cross-functional teams across APAC and beyond
Access flexible work arrangements, remote work options, and global benefits
Be part of a mission-driven culture focused on patient safety and innovation
Job Type | Permanent Full-time |
Salary | Negotiable, based on experience |
Industry | Bank, Trust Bank |