給与 ¥7000000 - ¥9000000 per annum
担当コンサルタント Mina Choi
An excellent career opportunity for an experienced Regulatory Affairs Specialist has arisen at a global medical devices company. This role is suitable for an applicant with 3 years’ regulatory affairs experience and strong bilingual communication skills. As RA Specialist you will write Japanese submission files, monitor the pre-market approval process, and communicate emerging regulatory issues.
- Write and maintain Japanese submission files for CRM products; respond to regulatory agency inquiries
- Establish and maintain good working relationships with other CRM franchise teams (e.g., RA, R&D, marketing, operations, QA, and clinical research) involved in product development projects
- Review technical documents anticipated as key components of subsequent pre-market approval regulatory applications in cooperation with R&D, clinical, and QA teams
- Perform other related duties as directed by the RA Manager/Director
- Comply with all established company policies
- A bachelor’s degree, preferably in engineering
- 3+ years’ experience in regulatory affairs in Japan
- Written & spoken fluency in English and Japanese
- A strong communicator
- Proficient in MS Office – Word, PowerPoint, Excel
About the Company:
Headquartered in Europe, this medical devices manufacturer has established a strong presence spanning 100+ countries, delivering innovative medical technology to healthcare professionals in the area of cardiac health.
医療機器, ヘルスケア, エンジニアリング, 薬事