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QA/RA Specialist, Japan
RaySearch is a fast-growing international company and world leader in the field of advanced software for radiation therapy. Today, our solutions support thousands of clinics worldwide in the fight against cancer. We believe software has unlimited potential, and that it is now the driving force for innovation in oncology.
RaySearch Japan is now strengthening the team through the recruitment of a talented QA/RA Specialist to ensure that we comply with all applicable regulatory requirements and meet our quality and safety objectives. This fulltime position will be an addition to our existing team of 3 employees and located at our office in downtown Tokyo.
As QA/RA Specialist you will be responsible for compliance with regulatory requirements as well as for documentation and administration of RaySearch’s regulatory and quality work and processes. Your daily tasks will include investigation of applicable laws and regulations, filing of product registrations, administration of our quality management system, documentation and contact with authorities, post-market surveillance, participation in internal audits, and much more.
As a QA/RA specialist you are a tenacious deliverer with an eye for details. With responsibility for quality control and quality processes, you are well versed in Japanese medical laws and regulations.
- University degree in relevant field
- Minimum 3 years’ experience from quality assurance position
- Experience from regulatory work in medical device or pharmaceutical industry
- Experience from MAH license management and compliance with local quality and regulatory requirements in Japan
- Experience from QMS maintanence
- Administrative experience
- Knowledge of Japanese medical regulations and applicable standards
- Knowledge and experience of medical software is meriting
- Experience of document management is meriting
- Experience from working in an international environment is meriting
- Excellent language skills in Japanese and English (English: upper TOIEC 650)
- Excellent communication and organization skills
You are welcome to send your application including a resume marked with “QA/RA Specialist Japan” as soon as possible by clicking on the button below or by sending an email to email@example.com. Please include your possible start date.
For further information please contact Malin Stridh, HR Generalist, by email: firstname.lastname@example.org