Associate Director / Sr. Manager, Device Regulatory

---

募集要項

会社概要

同社は、日本国内において医療技術の研究開発と提供を行っています。特に、革新的な治療法の開発に注力し、がん治療に関する先端的な技術を提供しています。光免疫療法という新しい治療アプローチを用いて、がん細胞を標的とした効果的な治療を目指しています。この技術は、光と薬剤を組み合わせることで、選択的にがん細胞を破壊することが可能です。研究開発においては国内外の専門機関や大学との連携を強化し、臨床試験や実用化に向けた取り組みを進めています。医療分野における革新と患者の生活品質向上を目指し、日々努力しています。

業務内容

■ About the Role
As a regulatory leader, you will drive regulatory strategy for new and existing medical device products, supporting development programs from concept through commercialization.
You will collaborate closely with Global Regulatory Affairs, R&D, Clinical, Quality, and Commercial teams while serving as a strategic partner in navigating complex regulatory requirements across major markets, including the United States and Europe.
In addition to regulatory execution, you will contribute to strengthening regulatory capabilities, improving processes, and shaping best practices across the organization.

■ Key Responsibilities

• Regulatory Strategy
  • Develop and execute regulatory strategies for new product development and lifecycle management
  • Support global market access and product approval initiatives
  • Provide strategic regulatory guidance throughout product development
• Regulatory Submissions
  • Lead and manage regulatory submissions, including 510(k), PMA, IDE, and De Novo applications
  • Coordinate regulatory activities from pre-submission interactions through final approvals
  • Prepare and review regulatory documentation and submission packages
• Regulatory Compliance
  • Ensure compliance with FDA regulations, ISO 13485, CE Marking requirements, and applicable regulatory standards
  • Maintain regulatory documentation and support quality system compliance
  • Provide guidance on regulatory requirements and expectations
• Regulatory Intelligence & Risk Assessment
  • Monitor evolving regulatory requirements and industry trends
  • Evaluate regulatory risks and potential business impact
  • Develop risk mitigation strategies and regulatory recommendations
• Cross-Functional Collaboration
  • Partner with R&D, Clinical, Quality, Marketing, and other functional teams
  • Integrate regulatory requirements into development and commercialization plans
  • Provide regulatory guidance and training to internal stakeholders
• Health Authority Interaction
  • Support interactions with FDA and other regulatory authorities
  • Collaborate with Global Regulatory Affairs on agency communications
  • Manage regulatory inquiries and post-approval commitments
• Leadership & Process Excellence
  • Drive regulatory best practices and continuous improvement initiatives
  • Contribute to the development of regulatory capabilities and standards
  • Collaborate with global teams to enhance regulatory processes

━━━━━━━━━━━━━━━#spotlightjob3

応募条件

■Required Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or a related field
• 10+ years of Regulatory Affairs experience, including 5+ years in the medical device industry
• Experience with global regulatory submissions and product approvals (FDA, CE Marking, etc.)
• Business-level English proficiency

■Preferred Qualifications

• Advanced degree or RAC certification
• Experience with Class III medical devices, SaMD, or combination products
• Knowledge of EU MDR, MDSAP, and digital health regulations

給与

1000 - 1900 万円

勤務地

東京