Senior Regulatory Analyst - Life Technologies - Tokyo

Job description
Dx and IVD assay submission.
Manage the local regulation for LT products.
Training therelated regulation for our products.
Maintain the MAH, FOMA and other related lisences.

Position: Sr. Regulatory Analyst

Position Requirements：

・医療機器又は体外診断用医薬品の承認（認証）申
　請の実務経験者（3～5年程度）
　特に遺伝子解析装置、がんマーカー他経験者希望
・医薬品又は医療機器の業態管理経験者
・ビジネス英語：文献・技術文書の読解及びビジネス
　メールの作成
・Sr. Mgr RAQAに報告する
　

Preferred
・英会話中級レベル（TOEIC600点以上程度）
・薬剤師・臨床検査技師の資格があればなお可

Life Technologies is proud to be an Affirmative Action/Equal Opportunity Employer committed to hiring a diverse and inclusive workforce.

Minimum Qualifications (must have)

SKills in actual RA in Japan
Preferred Qualifications (nice to have)

Diagnostics RA experience, pharmacist.
EOE

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