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About the Role
Under minimum supervision, this role is responsible for understanding laws and regulations and efficiently conducting duties such as approval applications, notifications, and other related tasks for medical devices manufactured and distributed by Stryker Japan K.K.
Responsibilities
- Manufacturing and distribution/certification approval, notifications (including planning, project management, collecting data, and PMDA/NB query correspondence)
- Maintenance of approvals and certifications (Change control and periodical renewal)
- QMS compliance inspection applications
- Insurance listing applications (Creation of insurance listing application forms)
Requirements
- 3+ years of experience of medical device application approvals
- Good communications skills and project management skills
- Preferred if he/she has an experience of having PMDA/MHLW consultation meeting
- Preferred if he/she has knowledge/experience in Medical electrical equipment
- Ability to communicate efficiently with internal related sections such as QC, WA, Sales & Marketing, Operations, Customer Care and etc.
- Integrity and action-oriented mindset.
- Willingness to challenge inexperienced things.
Skills
- Communication skills
- Project management skills
- Ability to write business documents
- Ability to read and write English
Location
- Onsite
- Hybrid
Work Type
- Hybrid
- Onsite
Experience Level
- 3+ years of experience
About the Company
- Stryker Japan K.K. manufactures and distributes medical devices.