募集要項
- 募集背景
- A multinational medical device manufacturer is searching for a RA and QA Manager with a medical equipment background. In this positon, you will be responsible for assuring product quality and safety and enforcing compliance of the company's operations to local regulations governing medical devices.
- 仕事内容
-
A multinational medical device manufacturer is searching for a RA and QA Manager with a medical equipment background.Responsibilities:
* Coordinate RAQA activities with Global Regulatory Affairs, Quality Assurance and Legal Counsel teams to ensure the products' quality and their compliance with regulatory requirements
* Prepare and confirm new medical device application forms
* Confirm if the products, the labels on the products and advertisements meet the local regulatory requirements before going onto market
* Establish, apply and manage GQP and GVP
* Act as a liaison for external audit activities and government authorities
* Attend required RA seminars and conduct internal training for associates
Requirements:
* Expertise in laws and regulatory requirements related to medical devices
* Experience in medical device sales application
* Bachelor's degree in a scientific discipline and experience in experiment or instrumental analysis
* Business level proficiency in English
* Experience in working for multinational medical device companies
- 応募資格
-
- 必須
- Expertise in laws and regulatory requirements related to medical devices
- 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
- JPY6,000,000.00 - JPY10,000,000.00 per annum