Job Title 【品川】薬事スペシャリスト/Regulatory Affairs Specialist (Q＆R） Job Description 【業務内容】 大型診断機器、もしくはスリープ＆レスピラトリーケア（睡眠・呼吸）領域の製品の薬事申請実務を担当していただきます。 ・製造販売承認／認証申請、届出（計画...
The RAQA Specialist II will be responsible for providing regulatory and quality support to meet company goals. This includes ensuring compliance to RA, QS...
Main Mission of Job 新製品の本邦への導入及び既存製品の維持を行うことで医療現場に品質及び安全性の高い製品を提供する。 Main Responsibilities “A Day in the Life” Medtronic SPINE事業部では、超高齢社会において増加し続ける椎間板ヘルニアや腰部脊柱管...
null 【業務内容】 当社主力製品であるスリープ＆レスピラトリーケア（睡眠・呼吸）領域の製品の薬事申請実務を担当していただきます。 ・製造販売承認／認証申請、届出（計画立案、資料取集、PMDA／NB 照会対応） ・承認／認証の維持管理業務（変更管理、定期更新） ・QMS適合性調査申請 ・保険収載業務（保険適用希望書作...
The Jobs Mission Under minimum supervision by Manager and Lead Specialist, he/she understands the laws and regulations, and efficiently conducts the duties...
The Jobs Mission Under minimum supervision by Manager and Lead Specialist, he/she understands the laws and regulations, and efficiently conducts the duties...
The Jobs Mission Under minimum supervision by Manager, he/she understands the related laws and regulations, and efficiently conducts the duties such approval a...
- Manage the receipt, processing and quality review of expedited safety reports (ESRs) to Japan PMDA. This includes, but is not limited to - maintenance of adve...
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic dis...
Location: Tokyo Department: Life Science- Quality & Regulatory Management Japan Report to: Head of the department in Japan Direct reports: 0 (Japanese follows...
Location: Tokyo Department: Life Science- Quality & Regulatory Management Japan Report to: Head of the department in Japan Direct reports: 0 (Japanese follows...
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic dis...
Primary Responsibilities include: Support Market Access strategies in Japan to enhance patient access to Edwards’ technologies Develop materials to demonstrate ...
* Responsible for management of Clinical Quality oversight of each project and/or trial level to ensure adherence to Quality & Compliance guidelines * Responsib...
* Export Trade Control classification/H S code/Chemical regulatory screening and prepare and submit the related applications and documents for chemicals...
※Applicants must have permission to work in Japan and required fluent ~ native level Japanese. [Company Description] 外資系化学メーカー 医療・エレクトロニクス・ファブリクス等の各分野にて、とても斬新で市...
DEPARTMENT: SPINE MARKETING REPORTING TO: Sr. MARKETING MANAGER LOCATION: TOKYO or Osaka Main Mission of Job “Careers that Change Lives” Develop and execute bus...
