QRC, PMS Specialist
Primary stack
Quality AssuranceMarketing
Nice to have's
CommunicationProject ManagementMS Office
Job description
About the Position
Job Overview
Getinge Group Japan K.K. is seeking a QRC, PMS Specialist in Tokyo, Japan. This role involves ensuring compliance with safety management and quality systems for medical devices.
Responsibilities
- Ensure compliance with safety management and quality systems for medical devices.
- Collaborate with global and local quality management systems.
- Handle safety management information and corrective actions.
- Coordinate with relevant departments for smooth operations.
- Report to the safety management supervisor.
Requirements
- Bachelor's degree or equivalent experience.
- 2+ years of experience in medical device safety management.
- Knowledge of the Pharmaceutical Affairs Law and GVP Ordinance.
- Familiarity with ISO 13485:2016 and ISO 14971:2019.
- Deep product knowledge of at least one product line.
- Strong communication skills with global teams.
- English proficiency for communication with global/regional counterparts.
Nice to Have
- Experience with MS Office applications.
- High IT literacy.
We Offer
- Competitive salary: 5,500,000 JPY - 7,800,000 JPY annually.
- Full-time position with flexible working hours.
- Annual leave: 125 days or more.
- Comprehensive social insurance.
- Annual performance review and salary adjustment.
About the Company
Getinge Group Japan K.K. is committed to providing innovative medical technologies and services. Learn more about our core values and employee experiences on our Meet our Employees page.
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