The Compliance Associate works closely to maintain regulatory compliance to include federal, state, or similar standards. This role will develop, implement, maintain, and support our Quality Management System (QMS). This role is responsible for evaluating site compliance, Internal/External Audit preparation and follow through, providing guidance to handle any regulatory impacts identified with respect to new products and services, and assists management with providing support for the development of documented business controls that are designed to mitigate compliance risks.
Equal Opportunity EmployerThis employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
What We Do
Our team helps medical device and pharmaceutical product manufacturers bring innovative, compliant and highly effective products to market with world-class expertise and extensive, independent testing capabilities at accredited facilities in the UK and USA. Our experienced medical device and extractables and leachables (E&L) testing teams will provide advice, guidance and recommendations as well as delivering test data to help you demonstrate compliance to regulatory guidance or specifications set out by the FDA, EMA, MHRA, USP, ASTM and ISO. Smithers also supports the pharmaceutical industry and the development of biologics and vaccines from discovery through phase IV, with expertise that includes bioassays and high sensitivity assays. Our scientists have expertise in large molecule bioanalysis assay development, validation, and sample analysis.
