Steven M. Smith

About Steven M. Smith

Healthcare Professional with a unique blend of Operational and Regulatory experience; diverse in Manufacturing, Distribution, Quality and Regulatory Affairs. Strong analytical skills and ability to lead teams to effectively resolve issues and develop innovative solutions. Recognized for supporting strategic initiatives and change management processes within CAH and external suppliers and manufacturers of drugs and medical devices. Specialties: Regulatory- Medical devices and drug commodities Process improvement Quality systems Manufacturing Distribution Business unit management Training and development Project management Auditing Responsible for supporting the Cardinal Health organization that include; Sales, Marketing, Global Sourcing and Global trade as well as all Medical device and Drug suppliers and manufacturers that support Cardinal Health. Responsibilities include addressing all levels of Regulatory, Quality regulations within the Medical and Pharm Industry to include US federal and foreign regulations related to the medical industry. Current role, I Manage a team that is a critical focal point between Marketing, Global Sourcing, Global Trade, various Platform Teams, Manufacturing Sites and External Customers. Managed a review of FDA regulatory data, where data is proactively reviewed and confirmed to support a manufacturing process in excess of $900M. Participate and direct decisions and policies regarding internal approaches related and management of systems that provide regulatory validations and clearance. Believed to be a subject matter expert related to Convenience kit manufacturing and all applicable regulatory guidance’s which includes extensive dialog with FDA regulators and suppliers of medical related products. Primary responsibility is to ensure regulatory compliance of the kit division of CAH which has an estimated VOP of 900m

Experience

1. Raqa Manager

   Cardinal Health

   Aug 2005 — Present

   Regulatory Affairs Manager at Cardinal Healthcare