Senior Regulatory Affairs Specialist (Cardiovascular @ Tokyo)

Medtronic · Tokyo, Japan

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RegulatoryFull-timeCompany career page

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What they're looking for

Bachelor's degree in science or equivalent qualification
Experience with medical device or pharmaceutical regulatory submissions
English proficiency for technical communication and US headquarters coordination
Japanese written communication and documentation skills
Project management and teamwork capabilities
Proficiency in Word, Excel, PowerPoint
Class IV medical device submission experience preferred

What you'll be doing

Develop regulatory and insurance submission strategies for cardiovascular devices in collaboration with US headquarters and marketing
Prepare and submit high-quality regulatory applications to Japanese authorities for product approvals
Create insurance reimbursement applications and coordinate evidence collection for insurance classifications
Maintain timely and accurate information exchange with US headquarters on regulatory matters
Monitor domestic and global regulatory developments and industry standards in cardiovascular field

Key requirements

Therapeutic area: Cardiovascular

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Date posted18 days ago

Last source check1 day ago

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