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Danaher Corporation Sr. Regulatory Affairs in Suzhou, China

  • interpret federal, state, provincial, and international regulations as they apply to Beckman Coulter products, processes and/or procedures; advises on impact of regulations, and devises strategies to compliance. They may liaise with external regulatory, government, or other associated agencies. Secures necessary country licenses (country approvals), certificates (e.g. CFGs), and renewals (e.g. CE renewals) required to market products in strategic geographies. Ensures company complies with the local regulatory requirements of the country in which the product is marketed. Prepares the necessary documentation, secures necessary approvals, executes on product recalls, and responds to regulatory agency inquiries.

  • work as core team RA to support the design, development, manufacturing, and marketing of Beckman Coulter devices. This role may also require assessment of manufacturing processes and pre/post market compliance with local and international regulations, directives, and standards.

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.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.If you’ve ever wondered what’s within you, there’s no better time to find out.