Job Description
About the position
The Sr Specialist in Regulatory Management at Cardinal Health is responsible for ensuring compliance with regulatory requirements and enhancing supply chain integrity. This role involves developing and implementing policies and procedures, leading quality management efforts, and providing guidance on regulatory matters. The position requires a strong understanding of regulatory changes and their impact on business operations, as well as effective communication with various stakeholders.
Responsibilities • Responsible for execution of recalls/field actions globally • Includes regulatory body communications and required recall/field action effectiveness updates • Primary responsibility of completing Distribution Center (DC) and customer notification of recall/field actions • Completes data inquiries to support management review activities and leadership updates • Supports DCs with recall effectiveness inspections and other regulatory/accreditation inspections • Demonstrates knowledge of regulatory requirements and utilizes depth and breadth of experience to assess regulatory changes, risk and business impact • Develops, implements and maintains standard operating procedures, programs and processes to ensure conformance with quality, regulatory and company requirements • Applies thought leadership and expertise to assess, evaluate, manage, mitigate and balance risk and enhance business performance • Provides ongoing guidance and direction to operations personnel regarding regulatory and quality matters • Monitors Federal, State, and local regulatory activities in order to implement new Company procedures or update existing procedures to facilitate compliance • Serves as liaison with local, state and federal government agencies.
Requirements • Bachelors in related field, or equivalent work experience, preferred • 2+ years' experience in related field, Quality preferred • Quality background in regulated industry, recall/field action management strongly preferred • Strong analytical and technology skills • Experience with bolthires Office suite programs • Effective communicator able to work cross-functionally to achieve results. Benefits • Medical, dental and vision coverage • Paid time off plan • Health savings account (HSA) • 401k savings plan • Access to wages before pay day with myFlexPay • Flexible spending accounts (FSAs) • Short- and long-term disability coverage • Work-Life resources • Paid parental leave • Healthy lifestyle programs Apply tot his job