The Analyst Regulatory Affairs associates interpret Chinese regulations as they apply to Beckman Coulter products, processes and/or procedures; advises on impact of regulations. They may liaise with external regulatory, government, or other associated agencies. Ability to independently support assigned project task, ensure to obtain production licenses, product registration certificates, registration changes, etc. within a reasonable time. Ensure that the company's products comply with China's regulatory requirements. Prepares the necessary documentation, secures necessary approvals, meet post-market obligation (such as assembling adverse events and conducting analytical investigations, adverse event reporting, product recalls), and responds to regulatory agency inquiries. Support product registration activities as a document author or reviewer. Performs technical reviews, as applicable. Require collaboration with line manager or Staff on technically complex technical reviews. The Analyst Regulatory Affairs should be a Core Team RA and support projects registration in Chinese market.

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