RAマネージャー/ RA Manager | ロバート・ウォルターズ・ジャパン株式会社/Robert Walters Japan K.K.の求人詳細

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更新日 2018-10-11
掲載開始日 2018-10-10

RAマネージャー/ RA Manager

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この求人の
取扱い会社
人材紹介
ロバート・ウォルターズ・ジャパン株式会社/Robert Walters Japan K.K.
企業名 外資系医療機器メーカー
職種
ロバート・ウォルターズ・ジャパン株式会社/Robert Walters Japan K.K.
法務 - 法務(コンプライアンス)
業種 医療機器メーカー
勤務地 アジア 日本 東京都

仕事内容 An American medical devices company is searching for a Regulatory Affairs Manager. This position will be responsible for ensuring compliance to regulations throughout the company and coordinating with regulatory bodies. This is a great opportunity to advance your career with a global company.

Responsibilities:

* Cooperate with the sales and marketing teams to give daily regulatory support and guidance
* Serve as the point of contact for all regulatory related matters and maintain good relations with regulatory bodies
* Conduct regular reviews and training with distributors and company personnel to ensure compliance to regulations
* Maintain an up to date knowledge of Japanese regulations and regulatory bodies and interpret requirement to advise corporate personnel on changes
* Lead and assist regulatory and QA projects and take corrective actions involving regulatory authorities
* Work with your regulatory team to provide necessary documents in a timely manner including Shonin, Ninsho, and Todokede medical device applications
* Oversee department management responsibilities including budgeting, hiring, termination, training, performance reviews, and dispute resolution

Requirements:

* B.S. in engineering or scientific field
* 5+ of regulatory affairs experience in a medical device company including experience interacting with regulatory bodies and legal counsel
* Experience with processing Shonin, Ninsho, and Todokede applications
* Willingness to accommodate flexible working hours based on project requirements
* Team management experience
* Microsoft Office proficiency (Word, Excel, Access, and Outlook)
企業について
(社風など)
A multinational medical devices and technology group based in the United States, this organization creates products that are widely used in the healthcare industry.

Keywords:

法務, 法律, コンプライアンス, 医療機器、トレーニング, 研修

1116180/001
英語能力 ビジネス会話 (TOEIC 735-860)
年収 日本・円 1000万円 〜 1500万円   
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