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.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.