
高級法規事務注冊專員_RA&C_上海

職位描述
POSITION SUMMARY
Reporting to the Senior Regulatory Affairs Manage, works with a team of regulatory affairs professionals to ensure establishes best practices within the assigned area of responsibility. E.g. CFDA Pre-market approval submission & regulatory reporting, design controls for new product development, technical standards, collection and dissemination of intelligence, influencing the global regulatory environment, etc.
KEY RESPONSIBILITIES
1. Prepare pre-market submissions (including type testing, registration files etc.) and obtain approval of premarket product registration timely.
2. Acts as the Regulatory partner for the BU he/she is responsible for.…
3. Interact with CFDA on registration requirements and monitor changes to requirements.
4. Independently manages and provide regulatory guidance to multiple long-term projects without direct supervision.
5. Manages a single discipline within the unit on a project or short-term basis.
6. Interacts with manager as required by specific issues, milestones, or status changes.
7. Represents BD externally in long term project in specific fields.
8. Accepts accountability for RA within BD on multi disciplinary platforms.
9. Manages the regulatory review of labels, labeling, promotional materials, clinical protocols, and clinical reports for products that are under his/her responsibilities.
10. Ensures compliance with regulatory requirements, including but not limited to change management, Chinese labeling requirements, etc.
11. Monitors regulatory and Standards developments affecting BD product he/she is responsible for, Identifies and recommends committees that BD should be part of.
DESIRABLE
B.S. or B.A. degree in a technical discipline (electrical engineering, bioengineering, chemical, biology, pharmaceutical preferred).
企業簡介
Founded in 1897, BD is a world-wide leader of medical technology which manufactures and sells a broad range of supplies, devices and systems for use by healthcare professionals, medical research institutions, industry and the general public. We focus strategically on achieving growth in three worldwide business segments-BD Medical System (Core Medical, Consumer Healthcare, Pharmaceutical Systems, Ophthalmic Systems), BD Biosciences and BD Preanalytical Solutions. Our products are marketed in the United States and around the world. The latest Fortune magazine has listed BD in the top four “America’s Most Admired Companies” in the medical products, equipment category.
We believed in “Do what is right, Always seek to improve, Accept personal responsibility, Act in harmony.” Now we invite qualified, talented and self-motivated individual to develop with BD’s businesses in China.
上海相關職位: 銷售經理(新生兒、醫療) 銷售經理(呼吸醫療) 工藝員 微生物檢驗員 維系保養員/電工 (MJ002499) QA體系專員 驗證專員/主管 QC化學分析員 (MJ002498) QA質量管理員(體系/驗證/注冊)
熱門區域招聘: 重慶 北京 上海 浙江 江蘇 廣東 山東 湖南 安徽 河北
上海招聘企業: 上海拓康方舟醫療科技有限公司 易葫蘆(上海)醫藥科技有限公司 百進冠合(海南) 醫療科技有限公司 上海華茂藥業有限公司 上海信誼藥廠有限公司 上海強生制藥 歐姆龍健康醫療(中國)有限公司 青海瑞成藥業(集團)有限公司 上海交通大學醫學院附屬瑞金醫院 復旦大學附屬中山醫院
職位發布日期: 2019-04-23

