Compliance and Regulatory Professional

21 hours ago

San Diego, California, United States CorDx Full time
Job Description

Company Overview

CorDx is a multinational biotechnology organization dedicated to pushing the boundaries of innovation and supply in global health. With a global presence and a team of over 2,100 employees, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious diseases, pregnancy, drugs of abuse, biomarkers, and more.

Job Summary

The FDA Compliance and Regulatory Specialist will be responsible for ensuring the company's compliance with FDA regulations and guidelines in the food and drug-related business. This role will involve tracking and updating FDA regulatory changes, collaborating with relevant departments to develop compliance training and policies, and ensuring the company's compliance program is effective and up-to-date.

Key Responsibilities

  • FDA Regulatory Compliance
    • 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.
  • Compliance Program 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.
  • Compliance Training and Awareness
    • 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.
  • 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.
    • 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

CorDx offers a comprehensive benefits package, including medical insurance, retirement plan, paid time off, and training and development opportunities.

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