RA specialist / RAスペシャリスト
Date: Apr 10, 2025
Location: Chuo-ku, Tokyo, JP, 104-0061
Company: Dentsply Sirona, Inc
Requistion ID: 79799
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Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona’s products provide innovative, high-quality and effective solutions to advance patient care and deliver better and safer dentistry. Dentsply Sirona’s global headquarters is located in Charlotte, North Carolina, USA. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY. |
This position is responsible for pharmaceutical affairs applications for our company's products and the associated pharmaceutical affairs-related practical work.
・Performs pharmaceutical affairs applications for dental products (equipment, dental materials, implants, etc.).
・As a member of the pharmaceutical affairs department, has awareness and understanding of the Pharmaceutical Affairs Act.
・Obtains manufacturing and sales approval and certification for medical devices (Class I-III), and handles and notifies of changes.
・Manages business conditions under the Pharmaceutical Affairs Act, such as manufacturing plant registration.
・Preparation and submission of applications for insurance coverage.
<Main points of communication>
Headquarters (Europe, Americas) Design, development, quality assurance, marketing department staff
Company sales, marketing, service department staff
<Required>
Experience in medical device regulatory affairs applications
English: Business-level reading and writing
<Desirable>
English: Business-level speaking, reading and writing
Experience in regulatory affairs applications for dental products
Experience in regulatory affairs applications for implant products
当社製品の薬事申請及びそれに付随する薬事関連実務業務を行うポジション。
歯科用製品(機器類、歯科材料、インプラント等)に関して薬事申請実務を行う。
・薬事部門として、医薬品医療機器等法に対して認識・理解を持つ。
・医療機器（クラスⅠ~Ⅲ）の製造販売承認、認証の取得、並びに変更事項の対応、届出を行う。
・製造所登録等の医薬品医療機器等法下での業態管理を行う。
・保険適用希望書の作成提出。
＜主なコミュニケーション先＞
本社（欧州・米州）設計、開発、品質保証、マーケティング部門担当者
当社営業部門、マーケティング、サービス部門担当者
<必須>
医療機器の薬事申請業務経験
英語：ビジネスレベルの読み書き
<歓迎>
英語：ビジネスレベルでの会話、読み書き
歯科用製品の薬事申請業務経験
インプラント製品の薬事申請経験
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