Your New Career Opportunity
We are searching for a Director of Regulatory Affairs. This is the perfect role for a Regulatory Affairs professional with experience in the medical device sector. There is a rewarding compensation package for this position.
This is a global medical device company that manufactures and sells consumable medical devices ranging from Class II to IV. Within their industry, they are well known for the quality of their products and have a 60% market share while maintaining double-digit growth over the last several years. The future is bright with several product launches planned over the next several years.
- Work on Quality and Regulatory Processes to meet the regulatory requirements that are needed in regards to the local laws (Pharmaceutical and Medical Device Act and internal regulations). Mainly responsible for QMS works.
- Lead GVP/QMS works in cooperation with International RA/QA team and other stakeholders.
- Registration of medical devices and Business license maintenance.
- Corresponding to the inquiries from JP authorities (MHLW, PMDA, and Notified Body).
- Seeking reimbursement through the Regulatory Affairs process.
The Skills and Experience You Need to Succeed
- Experience with Regulatory Affairs submission process.
- Experience with the registration of medical devices.
- 2+ years’ experience in the RA field.
- 5+ years’ experience in medical device company is required.
- Basic computer skills (Word, Excel, PowerPoint) are necessary.
- Native-level Japanese language skills.
- Business-level English language skills.
The Benefits You Will Receive
- Highly competitive salary package.
- Work in a central Tokyo location.
- International environment.
- Speak English in a supportive team.