My client is an international medical Equipment Manufacturing company, supporting hospitals and life science institutions with Class III and Class IIII medical devices in their most important task - saving lives.
- Role: QcRM/QRC, Regulatory Affairs Specialist
Location: Tokyo, Japan
Requirement:
- Bachelor's degree from a four-year university (or junior college)
- Experience in pharmaceutical affairs, quality, development, etc. in the pharmaceutical or medical device industry (Class III or higher)
- More than 5 years of experience in regulatory affairs application
- Native in Japanese, conversational English
Responsibilities:
- Under the guidance of the supervisor, collaborate with the manufacturer and other related departments to carry out tasks such as product introduction
- Obtains or supports the obtaining of permits and approvals for assigned products. In the process of obtaining permits and approvals, may need support in making general policy decisions and developing strategies, but will generally carry out the entire process on his/her own and obtain permits and approvals.
- Develop good working relationships with government authorities
- QcRM, QA/QMS Senior Specialist
Location: Tokyo, Japan
Requirement:
- Proven track record of successfully developing strategies that lead the team to success
- Familiar with Japanese regulatory requirements and ISO 13485 standards
- Practical operational experience with SAP
- Native in Japanese, conversational English
Responsibilities:
- Support QA&QMS Manager
- Communicate and execute quality control strategy consistent with global strategy
- As a team leader, build a strong team within the organization and develop staff
- Establish, implement and maintain all procedures managed by GGJ in line with the Global QMS
- Acceptance inspection and determination of market release, and management of suspension measures for all products
- Foreign manufacturing registration
- Supplier and Distributor Control
- Build cooperative relationships with administrative agencies (MHLW, PMDA, TMG, etc.)
For further information about this position please apply.
