Location

Tokyo

Department

Quality

GVP Specialist - Anseki 安全管理責任者

Do you have experience of Good Vigilence Practice management and want to improve cancer care for patients around the world? Join RaySearch Japan as our GVP Specialist (Anseki 安全管理責任者)!

About the role

RaySearch Laboratories is a world leader in the field of advanced software for radiation therapy. As GVP Specialist you will be responsible for establishing and maintaining Good Vigilance Practice (GVP) procedures and supporting our quality assurance process in Japan. You will be part of a committed and competent team at our office in downtown Tokyo, and work closely with the international QA/RA team based at RaySearch Laboratories' head office in Stockholm, Sweden. In a flexible work environment, you will have the opportunity to collaborate with our QMS manager (Hinseki (国内品質業務運営責任者)) and to learn QMS duties if you wish.

Your main tasks

  • Establishing and maintaining Good Vigilance Practice (GVP) procedures
  • Managing Post-Marketing Surveillance, safety information and safety measures
  • Maintaining safety notice handling in the Japanese market
  • Filing of product quality and safety reports to authorities
  • Supporting in Quality Management System (QMS) administration 

Your profile

To be successful in this role you need to be well-organized and knowledgeable in Japanese medical device regulations. We believe that you can work independently and that you have an understanding of how to set up efficient processes based on the company's business. This position includes communication with both RaySearch colleagues and external parties, and therefore you also need to be a good communicator that enjoys collaboration and express yourself well both in Japanese and English. Working with quality assurance for a software company, you should also have a strong interest in learning new skills and understanding our software functionality to explain it to relevant authorities.

  • University degree in relevant field of studies
  • Minimum 3 years of hands-on GVP experience in medical devices
  • Experience of working with Class 2, 3 or 4 medical devices - class 3 or 4 preferred
  • Native Japanese, English in business level (TOEIC 650+)

It’s an advantage, but not required, if you also have experience of working with software or working in an international organization.

Application

Please apply to the position through the application form below. Selection and interviews will be ongoing. We do not accept applications by e-mail, but if you have any questions about the position please contact Malin Stridh, HR Business Partner.

About RaySearch

RaySearch develops innovative software solutions to improve cancer care. Over 800 clinics in more than 40 countries use RaySearch software to improve treatments and quality of life for patients. RaySearch was founded in 2000 and is listed on Nasdaq Stockholm. The headquarters is located in Stockholm, with subsidiaries in the US, Europe, Asia and Australia & New Zealand. Today we are more than 380 employees with a common vision of improving cancer care with innovative software. Our great staff is crucial for our success and we offer a fantastic working environment in modern offices, flexibility and good opportunities for development. We believe in equal opportunities, value diversity and work actively to prevent discrimination.

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