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About the Role
Medtronic is a global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life. Join our team to shape the future of healthcare and build a career grounded in purpose, growth, and impact.
Responsibilities
- Manage regulatory affairs for spinal medical devices and biomaterials in Japan, including product introduction, maintenance, and lifecycle management.
- Handle new product approval applications, certification applications, and notifications.
- Manage existing approvals through variations, minor change notifications, etc.
- Conduct face-to-face consultations with PMDA regarding new product regulatory strategies.
- Evaluate regulatory impact of product changes and formulate response strategies.
- Coordinate and gather information on regulatory matters with overseas manufacturers (design originating from the US, with all documentation in English).
- Prepare regulatory documents such as package inserts and electronic inserts.
- Research and disseminate information on laws, notifications, and industry trends.
- Register and maintain data in internal systems.
Requirements
- Minimum 3 years of experience as a Regulatory Affairs Specialist.
- Experience with 10+ medical device minor change notifications (including certifications) or change notifications.
- Experience with 5+ medical device manufacturing and sales notifications (new).
- Experience with 3+ medical device manufacturing and sales approval variations (including certifications, excluding rapid manufacturing site variations).
- Experience with 1+ new medical device manufacturing and sales approval application (regardless of class).
- Experience with insurance application (Category A or B).
- General knowledge of regulatory affairs for medical devices.
- English proficiency (TOEIC 650+ or Eiken Grade 2+).
- Proficiency in Excel for data aggregation and management (functions, filters, pivot tables, etc.).
- Proficiency in Word for document creation.
- Proficiency in PowerPoint for presentation material creation and editing.
- Ability to manage online meetings and collaborate using Teams.
- Communication skills, including English, for general communication with design sources and review of application documents.
- Ability to accurately understand regulatory and product information, and approval details.
- Ability to appropriately grasp the intentions of others.
- Data management skills using internal systems.
- Ability to collaborate with stakeholders.
- Project management skills to manage multiple projects concurrently.
- Bachelor's degree or higher in a science or engineering field.
Skills
- Regulatory Affairs
- Medical Device Regulations
- English (TOEIC 650+, Eiken Grade 2+)
- Excel (Functions, Filters, Pivot Tables)
- Word
- PowerPoint
- Microsoft Teams
- Communication
- Data Management
- Project Management
Location
- Shinagawa Headquarters
Work Type
- Hybrid
- Flextime
Experience Level
- 3+ years
Education Level
- Bachelor's degree or higher in science or engineering
Salary/Compensations
- Competitive Salary
Benefits
- Flexible Benefits Package
- Medtronic Incentive Plan (MIP)
About the Company
- Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life.
- Our 95,000 employees work across more than 150 countries.
- We develop innovative medical technologies that improve the lives of 72+ million patients each year.
Equal Opportunity
- Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.
- Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.
- If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.
- If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com.