Associate Director / Sr. Manager, Device Regulatory

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Job details

Company overview

We are engaged in the research, development and provision of medical technologies in Japan. In particular, we focus on the development of innovative therapies and provide advanced technologies related to cancer treatment. We use a new therapeutic approach called photoimmunotherapy to target cancer cells for effective treatment. This technology combines light and drugs to selectively destroy cancer cells. In research and development, we are strengthening our collaboration with specialized institutions and universities in Japan and overseas to conduct clinical trials and commercialize the technology. We are committed to innovation in the medical field and to improving the quality of life of patients.

Responsibilities

■ 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

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Requirements

■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

Salary

10 - 19 million yen

Location

Tokyo