FDA Compliance Specialist
CorDx, United States

Position Overview: The FDA Compliance Specialist is responsible for ensuring the company's compliance with FDA regulations and guidelines in the food and drug-related business. They will oversee and manage the organization's compliance program, ensuring that the company's business processes align with FDA requirements. The FDA Compliance Specialist will also be responsible for tracking and updating FDA regulatory changes and collaborating with relevant departments to develop compliance training and policies.

Responsibilities and Duties:

• Familiarize and understand FDA regulations, guidelines, and requirements, ensuring alignment of company's business processes.
• 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 their 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 communicate and coordinate with regulatory agencies.
• Collaborate with internal teams to ensure compliance in product development, manufacturing, labeling, and sales.
• Participate in the preparation and submission of FDA approvals and registrations, providing compliance support and document management.
• Manage FDA-related records and documents to ensure compliance and timely archiving and documentation.
• Share the latest compliance requirements and changes with 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.
• Relevant bachelor's degree and prior experience in FDA compliance or regulatory affairs is preferred.

Benefits

insurance

welfare

Annual leave

Job Rewards and Benefits