■Position Summary:
We are seeking a Regulatory Affairs (RA) staff to join the Japan affiliate of a U.S.-headquartered global medical device company. This role is responsible for supporting regulatory submissions, approvals, and compliance activities to ensure timely market access of our products in Japan. The RA staff will work closely with internal stakeholders and regulatory authorities to maintain product quality, safety, and efficacy.
米国に本社を置くグローバル医療機器企業の日本法人で、薬事関連業務（RA）スタッフを募集しています。この職務では、日本における当社製品のタイムリーな市場参入を確保するため、規制当局への申請、承認、コンプライアンス活動のサポートを担当します。RAスタッフは、社内のステークホルダーおよび規制当局と緊密に連携し、製品の品質、安全性、および有効性を維持します。

■Principal responsibilities
Key responsibilities will include (but are not limited to) the following:
•Prepare and submit regulatory applications (new and variation) for medical devices in Japan
•Communicate and negotiate with regulatory authorities such as PMDA and MHLW
•Develop and execute regulatory strategies aligned with product lifecycle and business goals
•Collaborate with global RA teams, especially in the U.S. headquarters and APAC region
•Manage and maintain QMS documentation in accordance with local and global standards
•Coordinate with internal departments including Marketing, Quality Assurance, and Global RA
•Monitor regulatory changes and provide timely updates and guidance to relevant teams
•医療機器の薬事申請（新規・変更）および承認取得業務
•PMDA、厚生労働省などの規制当局との折衝・対応
•製品のライフサイクルに応じた薬事戦略の立案・実行
•米国本社およびAPAC地域のRAチームとの連携・報告
•QMS（品質マネジメントシステム）関連文書の作成・管理
•社内関連部門（マーケティング、品質保証、グローバルRAなど）との協働
•規制改定に関する情報収集と関係者への展開