RA Associate Manager_BW
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product registration related including new and renewal
handing registration process for S1/2 including document requirement dossier prepare, submit to CFDA, Follow up evaluation procedure, sample ordering type testing, solve various problems in whole process, file dossiers with consistent requirement;
Ensure to obtain the regulatory permits on time, in support of the organization's business plan especially product launch plan;
Establish working relationship with officials and experts in authorities, good communication and negotiation with officials and experts to guarantee smooth registration;
Pay attention to the market information such as the competitors with the analysis;
To coordinate the post surveillance project.
Medical or related education background and knowledge;
3-5 years medical device experience in regulatory affairs
good communication skills;
Good time management skills;
Well computer operating;
Better English and Chinese in Writing and oral
Johnson & Johnson Medical Shanghai Ltd. (7055)