Advisor, Regulatory Management

Cardinal Health

1d•Onsite

About The Position

Regulatory Management is responsible for the development and deployment of policies, procedures and programs designed to minimize risk, enable compliant business operations, products and services and drive uncompromised supply chain integrity. Demonstrates knowledge of regulatory requirements and utilizes depth and breadth of experience to assess regulatory changes, risk and business impact. Leads and directs efforts to assess the implementation of Quality and EH&S Management Systems to drive performance improvement and enhance supply chain integrity while preserving and optimizing system efficiency. 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
4+ years experience in related field, preferred
Experience with the FDA regulations, ISO 13485 experience and Quality Management Systems is desirable
Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
May contribute to the development of policies and procedures
Works on complex projects of large scope
Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives
Completes work independently receives general guidance on new projects
Work reviewed for purpose of meeting objectives
May act as a mentor to less experienced colleagues

Responsibilities

Demonstrates knowledge of regulatory requirements and utilizes depth and breadth of experience to assess regulatory changes, risk and business impact.
Responsible for the implementation and execution of the Cardinal Health Quality System at the Olive Branch, MS facility
Leads and directs efforts to assess the implementation of Quality Management Systems (QMS) to drive performance improvement and enhance supply chain integrity while preserving and optimizing system efficiency.
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.