FDA Compliance Specialist

5 days ago

San Diego, California, United States CorDx Full time
Job Title: FDA Compliance Specialist

**Job Summary:**

CorDx is seeking a highly skilled FDA Compliance Specialist to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring the company's compliance with FDA regulations and guidelines in the food and drug-related business.

**Key Responsibilities:**

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

**Requirements:**

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

**Benefits:**

  • Health Care Plan: Health Care Plan (Medical, Dental & Vision)
  • Retirement Plan: Retirement Plan (401k, IRA)
  • Paid Time Off: Paid Time Off (Vacation, Sick & Public Holidays)

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