You are responsible for

61 Participate in and advise cross-function new product/solution development teams on applications, requirements, and standards (not in the field)

61 Review development quality reports and plans to ensure that the information required for submissions is adequate;

61 Plan, generate, and coordinate regulatory submissions for product/solution licensing;

61 Coordinate testing required to support regulatory submissions;

61 Review and approve product/solution labeling and product/solution-related marketing communications (generally at BIU and Field)

61 Review changes in existing products to determine need for new/revised submissions or document reason for no submission.

61 Maintain existing regulatory filings /Licenses, managing updates and related change control processes (generally at the BIU and field level)



You are a part of Great China RA Team



To succeed in this role, you should have the following skills and experience

61 Bachelor’s degree above, major in medical or engineer

61 More than 5 years experiences in Q