Join a global healthcare and medical device company as a Senior Regulatory Affairs Specialist, working closely with global regulatory and development teams.
In this role, you will take ownership of Japanese regulatory authority interactions, leading product approvals, renewals, and change management activities.
This position offers strong long-term stability, global exposure, and the opportunity to contribute to medical devices that improve patient care and quality of life.
Key Responsibilities
- Lead regulatory submissions, renewals, and change applications for medical devices in Japan
- Act as the main point of contact with Japanese regulatory authorities, managing inquiries and responses
- Coordinate and communicate with global regulatory and development teams
- Support non-clinical and clinical-related regulatory activities
- Conduct regulatory reviews of product labeling and promotional materials
- Monitor regulatory trends and share updates internally to ensure ongoing compliance
Required Skills and Qualifications
Experience:
- BSc or a degree in science (Eg: life sciences, engineering, chemistry)
- 3+ years of Regulatory Affairs experience in medical devices (non-clinical experience acceptable)
- Hands-on experience with regulatory submissions, changes, and authority interactions in Japan
- Practical experience at a medical device manufacturer, or 3+ years of manufacturer experience if applying from a CRO
Soft Skills:
- Strong teamwork and collaboration skills across internal and external stakeholders
- Ability to manage multiple projects simultaneously and prioritize effectively
- Proactive, self-driven approach with strong ownership of responsibilities
Language Requirements:
- Japanese: Native level
- English: Business level (used for global collaboration and documentation)
Preferred Skills & Qualifications
- Experience covering both non-clinical and clinical regulatory activities
- Chemistry or related technical background
- Regulatory experience with Class II-IV medical devices
- Broader experience within the healthcare or life sciences industry
About the Company
Our client is a global healthcare and medical device company engaged in the development, manufacturing, and sales of medical devices. The company operates with a strong focus on regulatory compliance, quality, and R&D, while maintaining close collaboration with global teams. The Japan office plays an active role in contributing to global regulatory and business strategies.
Why You'll Love Working Here
- Flexible working style supported by a flextime system
- Stable replacement hire with a structured handover and long-term career outlook
- Opportunity to build a sustainable career while leveraging regulatory expertise
- Clear career path toward future manager-level positions
- Modern, stylish office located in central Tokyo
- Minimal overtime and a supportive, professional work environment
Don't Miss Out - Apply Now!
