My client is a global healthcare company that specializes in manufacturing medical devices and research for future applications in neuroscience.
They are currently looking for a Regulatory & Safety Controller in Japan.
Highlight: Opportunity to travel domestically in Japan and internationally
Location: Tokyo/Remotely in Japan
Responsibility :
- Prepare documents for regulatory submissions and registrations to PMDA/ARCB
- Submission of annual PMS reports to PMDA
- Maintain or develop procedures related to Safety Control with relevant guidelines and regulations in Japan
- Training on Medical Device Safety Control
Requirements:
- 2-3 years experience in Regulatory Affairs
- Experience/knowledge with QMS/ISO13485 preferred
- Class ll medical device, Class lll medical device is preferred
- Native Japanese and fluent English (reading & writing)
For further information about this position please apply.
