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:
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
- 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
- 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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