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.

Status: Full-time

Division: Alluminox Solution Div.

主な業務内容

 •担当テリトリーを大局的に俯瞰し、市場をどのように変化させるかというテリトリーマネジメントプランを立案、実行、更新する。

•アルミノックス®プラットフォームの価値最大化を遂行するプロフェッショナルとして十分な知識を身につけ、洞察を行い、成果に結びつける。

•主要担当施設の詳細な情報を把握する。（各ステークホルダーのニーズや影響力、院内動向や取り巻く環境）

•市場動向やトレンドを把握し、ビジネスに対する将来の機会やリスクを予測し予め対応する。

•正しい情報に基づいた担当施設の目標と課題を的確に設定する。

•最善の顧客戦略を立案、実行し、適宜迅速に修正を行う。

•担当テリトリーにおける KOLと良好な関係を構築し、効果的なテリトリー戦略に落とし込む。•連携する各パートナーに対し、影響力を発揮することで建設的な協業を促進する。

•会社の規則、規範及び業界の規範を守り、正しいビジネスを行う。

求める人物像

•市場を開拓するマインドをお持ちの方
•裁量権のある営業にチャレンジしたい方
•医薬品/医療機器の営業にとどまらず、もっと深く病院全体と話ができるような方
•病院組織の合意形成を促すため、意思決定プロセスに関わる各ステークホルダーの把握と折衝ができる方。メディカルスタッフと合わせて、経営部門や医事課、用度課、SPD(院内物流管理システム)等、バリューチェーンのコンサルタントとして活動できる方
•新しい治療法を市場で確立するため、個別アカウント攻略ベースの活動とあわせて、エリア/テリトリーのKOLや医療連携の関係性/仕組みを理解し、効果的な活用を促す事ができる方

歓迎要件

•医療機器メーカーご出身の方

•歯科関連機器営業職の方

•がん治療薬の担当経験をお持ちの方

•医療業界経験と合わせて、他業界経験もお持ちの方も歓迎します。（現職が医療業界でなくても可）

その他

 •写真付き履歴書および日本語職務経歴書をご提出ください。

•全国転勤可能な方。

Status: Full-time

Division: Legal & Compliance Div.

Position overview　

As a strategic business partner, this individual contributes to the company’s growth and success locally and globally from a legal and compliance perspective. This individual is required to enable business by analyzing the situation logically, assessing risk and benefit, and working closely and actively with various functions across the company rather than being conservative and behaving like a judge. This individual reports to the Head of Legal & Compliance Div.

Key Duties and Responsibilities 

• Collaborate with business functions to provide sound legal and compliance advice that aligns with the company’s strategic goals and supports overall growth.
• Draft, review, and negotiate a wide range of contracts both in Japanese and English.
• Participate in multifunctional committee reviews of press releases, promotional materials, and publications in oversight of commercialization activities.
• Plan and restructure compliance program, including organizing a global compliance committee, establishing an event management system, and monitoring general regulations such as privacy areas.
• Establish, revise, or repeal internal rules/policies/SOPs, including rules of approval authority.
• Lead initiatives to ensure company-wide understanding and compliance with relevant laws and regulations, including conducting internal training sessions.
• Provide sound advice on Intellectual Property(IP) area and operate IP management by collaborating with global patent team and business functions.
• Operate contract lifecycle management system and maintain its data accuracy.
• Operate services related to the Company Act.
• Streamline business processes in legal and compliance areas.
• Maintain or update content on the intranet.
• Support other affiliates; such as Taiwan and India as well as the Headquarter.

Desired Education, Skills and Experience

• Must have 5+ years of experience in legal and compliance roles within the pharmaceutical/medical device industry. Experience in reviewing promotional materials from a legal and compliance perspective aligned with industry regulations is strongly preferred.
• Demonstrated the ability to provide business-oriented solutions to complex problems.
• Excellent written and verbal communication skills with the ability to clearly explain complex legal or compliance matters to non-legal/compliance professionals in both Japanese and English are strongly preferred.
• Experience in Intellectual Property Management, especially patent management, is a strong plus.
• Demonstrated ability to work independently and proactively with minimal supervision.
• Proven ability to work with all levels of management and the general workforce, a strong sense of professionalism, and the drive to provide superb and timely support to internal clients.
• A high level of proficiency with IT tools and systems, including experience with legal tech solutions and compliance software.
• A bachelor’s degree in law or JD is required.  An Attorney’s license or patent attorney license in Japan is a plus.