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.
法務 - 法務（コンプライアンス）
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.
* 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
* 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)
A multinational medical devices and technology group based in the United States, this organization creates products that are widely used in the healthcare industry.
法務, 法律, コンプライアンス, 医療機器、トレーニング, 研修
|英語能力||ビジネス会話 (TOEIC 735-860)|
|年収||日本・円 1000万円 〜 1500万円|