Medical Device Quality Assurance Manager

Job type Permanent
Salary 8,000,000 JPY - 11,000,000 JPY
Reference 33090


  • Global Biotechnology company focusing on innovative precision based cancer therapies


  • Support Quality Assurance supervisor to achieve Japan Commercial Operations objectives from Medical device perspective
  • When Quality Assurance issue arises, lead to define the appropriate Quality measurement through the communication with the related internal, global and external parties.
  • Ensure full compliance with applicable regulations in Japan.
  • Oversee all activities or responsibilities that are delegated to external parties


  • Career development support (training and promotions)
  • Start up environment
  • Working with a diverse and motivated team with excellent work culture


  • 5+ years Knowledge of relevant in Quality Assurance in Medical Device industry.
  • Experience of managing Medical Device class Ⅱ or Ⅲ
  • Experience of complaint handling
  • Experience in both clinical and post-marketing environment.
  • Understanding of PMD Act, relevant regulations and guidelines.
  • Thorough knowledge of drug and medical device development process.
  • Very good communication and problem solution skill among cross-functional team.
  • Ability to communicate reading, writing, and speaking in English is strongly preferred. 
  • Bachelor's Degree in Science or related discipline
  • Knowledge of relevant in Quality Assurance in pharma industry is plus.
  • Strong Communication skill with external parties.