Regulatory Compliance in a Multi-National Organization

Jack Sorokin, Deputy General Counsel (Retired), Beckman Coulter, Inc, USA

The regulatory environment has changed substantially over the past sixty years. More countries are adopting what at times are conflicting regulatory programs. In addition, communication among regulators has increased. Companies can no longer structure their regulatory compliance programs by focusing on one or two major countries. Counsel today needs to follow a structured approach to evaluating compliance and creating a compliance program. This article suggests key steps to take and identifies some of the major considerations counsel will need to address in this process.

Jack Sorokin has had extensive experience as regulatory affairs counsel, most recently as Deputy General Counsel for Beckman Coulter, Inc., a leading international manufacturer and marketer of biomedical testing instrument systems, tests and supplies that simplify, automate and innovate complex laboratory processes. His practice has covered the range of regulatory issues, including medical device, environmental, occupational safety and health, hazardous materials, controlled substance, and transportation. His practice has also included corporate law and governance, SEC compliance, finance, risk management, supply chain, manufacturing, real estate, procurement, and import/export law. He may be contacted by email at jesorokin@gmail.com.

Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. The Company’s diagnostic systems are found in hospitals and other critical care settings around the world and produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use Beckman Coulter’s life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs.