・Applicants must have permission to work in Japan
・Applicants must be able to speak fluent ~ native level Japanese (Equivalent to JLPT N1)
☑外資系企業 ☑英語力が必要 ☑リモートワーク可能 ☑フレックス勤務
RA Principal Specialist
Provide support on a range of medical device and activities which include product submissions, develop regulatory strategies, change assessments, commercial supports, compliance related activities, systems/process improvements and other responsibilities aligned with medical device regulation and business goals.
Keep the good relationship with related authorization agencies.
- Develop and implement regulatory strategy and suitable yearly plan to ensure the actual registration operation per set timeline for all types of product registrations (includes product with clinical data)
- Author product submission/notification, correspondent letter to authority
- Directly communicate with local authority (MHLW/PMDA) upon implementing regulatory strategy and correspondent on submissions.
- Monitor regulation, policy and standard changes from government authorities that have impact to company's products.
- Assess regulatory impact on various product/process change
- Author reimbursement submission document
- Review and approve advertising/promotional material to assure compliance with governing advertising/promotion
- Collaborate with necessary internal/external source to proceed assigned projects
- Attend related industry meetings to gather latest information and input necessary company opinion with internal cross functional alignment
- Performs other duties as needed
Education & Experience
- Bachelor's Degree in related field, Science background preferred
- 7+ years' experience in medical device regulatory affairs including submission with clinical data
- Prior experience authoring and receiving approval of medical device SHONIN submission document with clinical data
- Prior experience on C1/C2 reimbursement submission preferred
- Comprehensive knowledge of current regulations and guidelines
- Fluent in Japanese/English reading, writing and communication
- Familiar with MS Office applications
- Strong project management skills
- Ability to adapt constant changes in fast pace
Seniority Level: Mid-Senior level
Job Function: Science, Other