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Regulatory Affairs Manager
| Hiring Company | 株式会社フィリップス・ジャパン |
| Location | Tokyo - 23 Wards |
| Job Type | Permanent Full-time |
| Salary | 7.5 million yen ~ 11 million yen |
Job Description
【求人No NJB2214555】
Your role:
Exciting opportunity to play an integral role in introducing new product/solution maintain regulatory compliance and leading transformation/improvement activities.
・Develop local regulatory strategy and lead the strategic discussion with related stakeholders to accelerate project development.
・Proactively identify risks within regulatory strategies plans products and propose alternate approaches.
・Plan and execute product registration aligned with local business needs.
・Maintain current registration approvals accordingly.
・Manage interactions with MHLW/PMDA and maintain a productive working relationship.
・Review/Author product registration document and reimbursement document.
・Proceed regulatory assessment and promotional material review.
・Supervise RA administration activities.
・Lead various transformation/improvement activities.
General Requirements
| Minimum Experience Level | No experience |
| Career Level | Mid Career |
| Minimum English Level | Fluent |
| Minimum Japanese Level | Native |
| Minimum Education Level | Bachelor's Degree |
| Visa Status | Permission to work in Japan required |
Required Skills
1. Experience. ・+7 years’ experience in medical device regulatory affairs ・Maintains general knowledge of PMD act ISO 13485 Radio act. ・Actual experience of authoring class III / IV medical device submission including SaMD and received approval. 2. Skills. ・Self motivated and able to prioritize to handle multiple tasks/responsibilities. ・Bachelor of Science Degree in a technical discipline （Master's preferred） ・Fluent in Japanese and EnglishJob Location
- Tokyo - 23 Wards
Work Conditions
| Job Type | Permanent Full-time |
| Salary | 7.5 million yen ~ 11 million yen |
| Work Hours | 09:00 〜 17:30 |
| Holidays | 【有給休暇】有給休暇は入社時から付与されます 有給休暇:初年度最大20日間（入社月により変動） ※詳細はオファー時にご確認くだ… |
| Industry | Medical Device |
Job Category
- Medical, Pharmaceutical and Healthcare > Patent Specialist, Academic
Company Details
| Company Type | International Company |
