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About the Role
This role serves as a bridge to deliver meaningful medical devices to Japanese patients, focusing on regulatory affairs for cardiovascular and DIB portfolios.
Responsibilities
- Engage in regulatory affairs related to endovascular treatment devices.
- Develop regulatory approval and insurance application strategies and work plans in collaboration with US headquarters and marketing departments, understanding product characteristics, development plans, market/business needs, and launch strategies for timely domestic introduction of new products.
- Create high-quality applications efficiently based on regulatory application strategies and work plans, consult with administrative authorities, and obtain approval.
- Prepare and submit necessary applications based on insurance application strategies.
- For Class C1 or C2 applications, collaborate with marketing and insurance departments to collect domestic and international evidence, prepare and submit insurance application forms, create explanatory materials, and negotiate with relevant academic societies and administrative authorities.
- Perform associated regulatory affairs tasks, such as model information registration and documentation preparation, for product distribution.
- Maintain good trust and communication with US headquarters to obtain necessary information timely and accurately, and take necessary judgments and actions for regulatory administration without delay.
- Collect the latest information and knowledge on domestic regulatory laws, global regulatory trends, and assigned product groups and related treatments.
- Propose industry-side ideas to the administration regarding standard creation, regulatory affairs, and insurance-related matters through industry activities.
Requirements
- Bachelor's degree (4-year university science and engineering degree) or equivalent.
- Experience in regulatory affairs application for medical devices or pharmaceuticals (experience with Class IV medical device regulatory applications is a plus).
- English proficiency required for information exchange with US headquarters and reading technical English.
- Japanese writing skills.
- Teamwork and communication skills.
- Project management skills.
- General PC skills (Word, Excel, PowerPoint).
- Desire for growth (motivated individuals are welcome).
Skills
- Regulatory Affairs
- Medical Device
- Pharmaceuticals
- English
- Teamwork
- Communication
- Project Management
- PC Skills
- Word
- Excel
- PowerPoint
Location
- Japan
Work Type
- Full-time
Experience Level
- Mid-level
Education Level
- Bachelor's Degree
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 to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year.
- We aim to realize a better tomorrow through continuous challenges.
- Medtronic is an exciting workplace full of rewarding work for its employees.
- We strive to rapidly embody our technological strengths to create meaningful innovations.
- Medtronic addresses global healthcare challenges and contributes to improving patients' lives.
- Founded in 1957, we developed the world's first battery-powered external pacemaker and have continued to lead the world in the cardiovascular field with groundbreaking products.
Equal Opportunity
- Medtronic offers a competitive Salary and flexible Benefits Package.
- A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.
- We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.