Regulatory & Reimbursement Consultant for Foreign Medical Device Company

• Secured the first approval in Japan of an implantable medical device for chronic heart failure utilizing overseas clinical trial data and the C2 reimbursement pathway
• Responsible for the expert panel meeting or special panel meeting in MHLW during the regulatory review process for many different medical devices
• Secured regulatory approvals using overseas clinical trial data for many implantable medical devices in the cardiac rhythm management business

Regulatory & Reimbursement Consultant for Foreign Medical Device Company

• Secured many device regulatory approvals using local clinical trial data
• Secured regulatory approval for the first new indication for a nerve stimulation device using overseas clinical trial data and the C1 reimbursement pathway
• Successfully received regulatory approval for many different products categorized as “new medical devices” in Japan, including me too category as well.
• Deep knowledge and experience with regulations associated with field actions for medical devices in Japan
• Strong understanding of the regulations surrounding the advertisement of medical devices in Japan
• Wealth of experience with regulatory project management and change assessment
• Participated in industry meetings and activities for cardiac rhythm management companies (JADIA) regarding the reimbursement process with MHLW

Regulatory & Reimbursement Consultant for Japanese Contract Research Organization (CRO)

• Support making reimbursement strategy of new medical device. (drug-combinated device)
• Support submission class 4 regulatory submissions. (drug eluting stent)
• Support regulatory assessment on change control.

Independent Regulatory and Reimbursement Consultant