The FDA Compliance & Regulatory Specialist

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