Regulatory Affairs Manager举报
1人
不限
不限
年龄不限
性别不限
微简历可投
职位描述
Regulatory Affairs Manager-Beijing
Shanghai BurmingNash Consulting is a leading provider of HR Consulting Services, we provide professional service within the industry . Now we are looking for a Regulator affairs manager for the medical device industry.
Job Description:
1. Develop and execute regulatory plans for registration projects including new products and renewal of licenses / authorizations including the budget and product standard
2. Prepare, classify and verify the relevant documents for new medical device registration application;
3. Submit new product registration application, track and support the approval evaluation and ensure that all relevant information is tracked, captured and reported timely;
4. Lead the RA function on assigned cross-functional project teams by establishing appropriate and effective communication within RA and other functions and ensure that project objectives and deliverables are aligned with regulatory strategy and objectives are met;
5. Monitor and notify applicable regulatory requirements to ensure that company's businesses are not negatively impacted and assure compliance with company and external standards;
6. Build the long-term professional relationship / partnership with all the external customers (Officials of SFDA, Test center, Center of medical device evaluation and National Standard & SFDA Industrial group, Pricing bureau. etc.);
7. Capture Medical Device Industry administrative policies timely;
8. Perform regular gap analysis of existing regulatory and Government Affair processes and propose optimal solutions in the spirit of quality improvement in company;
9. Lobby to NDRC and Pricing bureau for charge list and health insurance;
10. Fulfill tasks assigned by his/her supervisor;
11. Acquires a good technical understanding of the company products and the applicable Chinese standards.
12. Works independently and effectively to determine the best test centre to perform the tests, accompanies the test process by providing technical expertise and effective communication, including with the headquarter team.
13. Classifies the product to Chinese regulations; determines the appropriate documents required for the submission, collaborates effectively with the headquarter team to organize delivery of documents; prepares the submission in Chinese language to the SFDA.
Job Requirements:
1. Bachelor degree or above, the major in Law is preferable;
2. At least 5-year related career in medical device industry;
3. Familiar with the related regulations and laws in registration;
4. Close contact to SFDA, Test Center, Pricing bureau. etc;
5. Strong interpersonal skills and the capability of communication;
6. Proficient in English, both oral and writing.
If you are interested in this position please send your CV to Chris.sun@burmingnash.com