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| 部署・役職名 | Senior Regulatory Affairs Specialist |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
In this role, you will lead the process of getting advanced medical tests and software approved for use in Japan. You will act as a bridge between the company and government health agencies to ensure all new products follow local laws and reach patients safely. Responsibilities: － Design and lead plans to get medical products approved while meeting company goals and timelines. － Prepare and submit all necessary paperwork to Japanese health authorities for new product licenses. － Act as the main contact for government agencies to discuss and secure timely product approvals. － Work with research and sales teams to provide expert advice on regulatory rules and project risks. － Monitor changes in medical laws and manage updates for products that are already on the market. |
| 応募資格 |
【必須（MUST）】 － Bachelor’s degree or higher in a science, engineering, or public health field.－ 5＋ years of experience in regulatory affairs or clinical research. － Strong history of managing medical device approvals and quality system assessments. － Able to speak and write professionally in both Japanese and English. － Ability to negotiate effectively with government health agencies to meet deadlines. 【歓迎（WANT）】 － It is helpful to have at least three years of experience with medical software or cancer diagnostic tests.－ Knowledge of advanced genetic testing and how it works for patient care is a plus. － Experience working across different cultures and global teams is highly valued. |
| リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2026/01/23 |
| 求人番号 | 6612222 |
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- 会社規模31-100人
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転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です