- 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
【WHY YOU SHOULD APPLY】
- 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.