Medical Division Head, (Quality & Regulatory Division)

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Published:   2020/09/30


Full time


Medical Device


¥ 20,000,000 negotiable


Medical Division Head, (Quality & Regulatory Division)

Report line: CEO

QA/RA/Medical (3) Unit head reports

  • Manage approx. 50 staff of a very diverse team
  • Support local clinical studies for registration purpose as well as for higher clinical recognition
  • Support to obtain registration approval/certification
  • Collaborate with pharmaceutical industry for companion diagnostics for novel drugs
  • (>3 times market growth)
  • Represent IVD industry as a representative of EBC

As Head of Medical, Quality and Pharmaceutical Affairs, collaborate with our Global Headquarters and cooperate with domestic Key Opinion Leaders (KOLs) to maximize the clinical value of our innovative new products in Japan. We will establish a system and carry out domestic clinical research as needed.

In addition, you will be responsible for a series of processes for consulting and negotiating with the authorities and obtaining regulatory approval and insurance coverage. As for products after launch, the main task is to work with teachers of academic societies and on-site clinicians to educate the significance of measurement in on-site medical care and to spread it widely. In addition, you will be responsible for ensuring the quality of a wide range of products in cooperation with our Global headquarters and relevant authorities.