Position Summary

The Device Regulatory Senior Manager will work together with Global Regulatory Affairs to lead the regulatory strategy and documentation management from Device product perspectives to facilitate the submission processes for the development, approval, and commercialization of medical devices in the U.S. and other global market. This position requires a deep understanding of FDA regulations, as well as expertise in navigating the requirements of medical device development and regulatory compliance. The ideal candidate will ensure timely and successful regulatory submissions, manage relationships with regulatory agencies, and provide strategic guidance to cross-functional teams, including Regulatory Affairs department at Rakuten Medical.

Key Roles and Responsibilities

• Develop and Implement Device Product Regulatory Strategy: Create and execute regulatory strategies for new product development, approval, and lifecycle management, ensuring alignment with company goals and regulatory requirements including U.S. FDA, CE marking.
• Regulatory Submissions: Oversee and prepare high-quality regulatory submissions (e.g., 510(k), PMA, IDE, and De Novo applications) and manage the process from pre-submission meetings to final approvals.
• Regulatory Compliance and Documentation: Ensure compliance with U.S. FDA regulations (21 CFR Part 820), Quality System Regulations (QSR), CE marking and other applicable guidelines and standards (ISO 13485).
• Regulatory Intelligence and Risk Assessment: Conduct regulatory assessments and stay updated on changes in requirements, e.g., FDA regulations and guidance, analyse their impact on current and future projects.
• Cross-functional Collaboration: Provide regulatory guidance and training to R&D, clinical, marketing, and quality teams to integrate regulatory requirements into product development and commercialization plans.
• Agency Interaction: Work with Global Regulatory Affairs to serve as the liaison with the FDA and other regulatory agencies, managing agency interactions, responses to inquiries, and ongoing regulatory requirements.
• Team Leadership: Work with Global Regulatory Affairs and Device Technical team to establish best practices and maintain high standards in regulatory processes.

Desired Education, Skills and Experience

• Education
  • Bachelor’s Degree in Life Sciences, Engineering, or a related field.
  • Advanced Degree (Master’s, Ph.D., or JD) in Biomedical Engineering, or a relevant scientific discipline is preferred.
• Skills/expertise
  • In-depth Knowledge of Medical Device Regulations & Requirements, including FDA Regulations. Strong expertise in 21 CFR Part 820 (QSR), ISO 13485, and FDA guidance on medical devices.
  • Technical Writing and Documentation: Exceptional skills in preparing regulatory documentation and understanding technical data for submission.
  • Analytical and Strategic Thinking: Ability to assess regulatory risks, interpret regulatory requirements, and develop actionable strategies for complex regulatory challenges.
  • Project Management: Strong organizational skills with the ability to manage multiple projects and meet regulatory deadlines.
  • Leadership and Communication: Demonstrated leadership skills with the ability to communicate effectively with cross-functional teams and regulatory agencies.
  • Regulatory Certification (Preferred): RAC (Regulatory Affairs Certification) or equivalent certification is a plus.
  •  Preferred skills:
    • Familiarity with global regulatory requirements, including EU MDR, MDSAP, and other international regulatory frameworks.
    • Knowledge of emerging regulatory trends and digital health regulations, including software and AI-based medical devices.
    • Experience with investigational device exemptions (IDEs)
    • Experience in communicating in English with business partners and the ability to read, write, and speak in English is required
• Experiences
  • 10+ years of experience in regulatory affairs, 5+ years within the medical device industry, with a strong focus on the regulation requirements in major jurisdictions, e.g., U.S. FDA, CE marking.
  • Proven track record of successful regulatory submissions and product approvals in the major jurisdictions (e.g., 510(k), PMA).
  • Experience with Class III or higher medical devices is preferred; familiarity with combination products or software as a medical device (SaMD) is a plus.
  • Experience in managing cross-functional projects.

Required Documents:

Please submit your resume (履歴書and職務経歴書) in Japanese and CV in English.