Work independently or provide support within Regulatory Affairs related duties which include but not limited to: making new product submissions and revisions, communicate internally with team and global, and externally with Japanese authority and third parties, etc.
Duties and Responsibilities
• Create new documents for submission, or update documents for semi-new product submissions.
• Work related to the insurance application and import notification.
• Experience with the previously approved products (change, management support, etc.)
• Communicate, negotiate, and maintain strong relationship with Japanese authority such as PMDA.
• Occasional communication with global through email, phone, or video calls.
• Confirm contents of promotional materials, etc.
• Regulatory work experience of medical equipment, preferably with high class Medical Devices.
• Communication and negotiation with Japanese authority and overseas (e-mail, telephone.)
• Communication ability.
• University graduate or more.
• Straightforward, cooperative, and positive personality.
• Basic computer skills and the ability to use PowerPoint, Word, and Excel.