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About the Role
This role is responsible for preparing regulatory submissions for new or improved products to be launched in the domestic market, as well as related tasks. You will also handle administrative responses, monitor submission status, and report to internal stakeholders. The medical devices you will handle in the emergency and life-saving field are directly linked to patients' lives. By being involved in the regulatory approval and certification of these devices, you will feel a sense of mission to save patients' lives and a great sense of accomplishment.
Responsibilities
- Prioritize and plan work, responding flexibly to changes.
- Product submissions, license renewals, periodic reports, and registration with domestic and international regulatory authorities.
- Create necessary documents according to medical device class and collaborate with other departments.
- Liaise and coordinate with regulatory authorities and certification bodies.
- Handle investigations such as reliability surveys.
- Maintain regulatory files and databases.
- Review product changes and consider domestic regulatory impact.
- Lead regulatory compliance activities.
- Review and report on regulatory issues related to products.
- Acquire and maintain up-to-date knowledge of regulatory requirements.
- Communicate with overseas manufacturers.
- Promote projects in collaboration with other departments.
- Other duties as assigned by superiors.
Requirements
- Bachelor's degree in science or engineering, or equivalent.
- Over 5 years of experience in regulatory affairs submissions in the medical device industry.
- Experience in negotiations with regulatory authorities.
Skills
- Knowledge of MDSAP and European/international regulations.
- Understanding of manufacturing and change control, and sensitivity to regulatory trends.
- Understanding of engineering concepts and scientific terminology.
- Project management skills.
- Analytical and problem-solving skills.
- Negotiation skills with overseas manufacturers.
- Prioritization and time management skills.
- Ability to work autonomously without waiting for instructions.
- Resilience to pressure to meet regulatory reporting deadlines and internal requirements.
- Excellent interpersonal and communication skills (oral and written).
- Teamwork skills.
- Leadership skills within a team.
- Basic PC skills.
- Business English (beginner level or higher).
- Native-level Japanese proficiency.
Location
- Remote (primarily)
- On-site (as needed)
Work Type
- Remote
- Hybrid
Experience Level
- 5+ years
Education Level
- Bachelor's degree in science or engineering
- Associate degree in science or engineering
Benefits
- Opportunity to gain experience with high-risk products that are constantly being improved.
- Opportunity to be involved in new product submissions.
- Strong cross-functional collaboration within the Regulatory Affairs, Quality Assurance, Safety Management, and Technical Service departments.
- Ability to gain a higher perspective as a regulatory professional by understanding cases where lives were saved by devices you were involved in approving.
- Potential for career growth into Group Leader or Managerial roles.
- Product training provided.
- Opportunity to handle key products for each business unit.
- Flexible work arrangements with a focus on remote work.
- Online meetings for regular/irregular meetings.
- Mutual support and workload adjustment within the team during busy periods.
- A culture that values innovation and proactivity.
- Opportunity to build a unique career path aligned with the company's mission.
About the Company
- Acute Care Technology is dedicated to saving as many lives as possible.
- We foster a transparent culture that values innovation and proactivity.
- Our mission is to save lives.