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The Analyst Regulatory Affairs associates interpret Chineseregulations as they apply to Beckman Coulter products, processesand/or procedures; advises on impact of regulations. They may liaisewith external regulatory, government, or other associated agencies.Ability to independently support assigned project task, ensure toobtain production licenses, product registration certificates,registration changes, etc. within a reasonable time. Ensure that thecompany's products comply with China's regulatory requirements.Prepares the necessary documentation, secures necessaryapprovals, meet post-market obligation (such as assembling adverseevents and conducting analytical investigations, adverse eventreporting, product recalls), and responds to regulatory agencyinquiries.Support product registration activities as a document author orreviewer. Performs technical reviews, as applicable. Requirecollaboration with line manager or Staff on technically complextechnical reviews.The Analyst Regulatory Affairs should be a Core Team RA andsupport projects registration in Chinese market.

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