CorDx

The FDA Compliance & Regulatory Specialist

CorDx Atlanta, GA
CorDx

The FDA Compliance & Regulatory Specialist

CorDx Atlanta, GA
1 month ago 126 applicants

See who CorDx has hired for this role

Description

Position Overview: The FDA Compliance & Regulatory Specialist is responsible for ensuring the company's compliance with FDA regulations and guidelines in the food and drug-related business. The FDA Compliance & Regulatory Specialist will also track and update FDA regulatory changes and collaborate with relevant departments to develop compliance training and policies.

Responsibilities and Duties:

  • Familiarize and understand FDA regulations, guidelines, and requirements, ensuring alignment of the company's business processes
  • Participate in preparing and submitting FDA approvals and registrations, providing compliance support and document management
  • Oversee and manage the company's compliance program, including developing compliance strategies, processes, and operating procedures
  • Track and interpret changes in FDA regulations and guidelines, as well as relevant industry dynamics and trends
  • Evaluate the company's existing compliance policies and procedures, provide improvement recommendations, and ensure effective implementation and compliance
  • Assist in developing and implementing compliance training programs, ensuring employees' understanding and adherence to FDA requirements
  • Assist in organizing and managing FDA audits and inspections and communicating and coordinating with regulatory agencies
  • Collaborate with internal teams to ensure product development, manufacturing, labeling, and sales compliance
  • Manage FDA-related records and documents to ensure compliance and timely archiving and documentation
  • Share the latest compliance requirements and changes with the company's senior management and teams, providing compliance advice and guidance


Requirements

  • Solid knowledge of FDA regulations and guidelines and a deep understanding of the food and drug industry
  • Strong project management and organizational skills, capable of handling multiple compliance projects and tasks simultaneously
  • Excellent communication and coordination abilities, able to collaborate with multiple stakeholders
  • Analytical and problem-solving skills to interpret and address complex compliance issues
  • Familiarity with the development and implementation of compliance training and awareness programs
  • Excellent document management and record retention skills, with attention to detail and accuracy
  • Experience in highly regulated industries such as food, pharmaceuticals, or medical devices
  • A relevant bachelor's degree and prior experience in FDA compliance or regulatory affairs is preferred


Benefits

  • Health Care Plan (Medical)
  • Retirement Plan
  • Paid Time Off

  • Seniority level

    Associate

  • Employment type

    Full-time

  • Job function

    Finance and Sales

  • Industries

    Primary and Secondary Education and Non-profit Organizations

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