Regulatory Affairs Specialist - Tokyo, Japan

Date: Jun 15, 2024

Location: Chuo-ku, Tokyo, JP, 104-0061

Company: Dentsply Sirona, Inc

 

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.

 

Bringing out the best in people

 

As advanced as dentistry is today, we are dedicated to making it even better. Our people have a passion for innovation and are committed to applying it to improve dental care. We live and breathe high performance, working as one global team, bringing out the best in each other for the benefit of dental patients, and the professionals who serve them. If you want to grow and develop as a part of a team that is shaping an industry, then we’re looking for the best to join us.

 

 

Key Responsibilities

  1. 計画に従った医療機器の製造販売承認・認証の取得及び届出の提出

Acquisition of Shonin approval and Ninsho certification of medical devices according to the plan and submission of notifications

  1. 品目維持のためのQMS適合性調査及びサーベイランス調査対応

Respond to QMS conformity inspections and surveillance inspections for product maintenance

  1. 製品を市場で販売するために必要な手続きの対応(保険適用・薬機法以外の薬事関連法令順守)

Responding to necessary procedures for marketing products (insurance coverage, compliance with the laws and regulations other than PMD Act)

  1. 承認・認証・届出品目の薬事的メンテナンス

Regulatory maintenance of approved/certified/notified products

  1. 安全管理業務の対応

Respond to safety management operation