募集要項
- 募集背景
- 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.
- 仕事内容
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An American medical devices company is searching for a Regulatory Affairs Manager.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)
- 応募資格
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- 必須
- 5+ of regulatory affairs experience in a medical device company including experience interacting with regulatory bodies and legal counsel
- 歓迎
- 英語力必要。その他は詳細からご確認ください。
- 雇用形態
- Permanent
- 勤務地
- Tokyo
- 年収・給与
- JPY10,000,000.00 - JPY15,000,000.00 per annum
- 休日休暇
- 完全週休2日制, 土日祝日休み, 有給休暇