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Position Description

The Regulatory and TraceGains Specialist is responsible for ensuring compliance with regulatory requirements and managing the TraceGains system for documentation and supplier management. This role supports the team by assisting with the preparation and submission of regulatory documents, maintaining records, and ensuring that all products meet applicable laws and regulations. The specialist will also be responsible for managing data and documentation within the TraceGains system, ensuring accuracy, and supporting continuous improvement efforts.

Key Responsibilities:

1. Regulatory Compliance Support:
• Assist in the preparation and submission of regulatory documents, including product registrations, certifications, and licenses.
• Maintain up-to-date knowledge of FDA, USDA, and other relevant regulatory requirements.
• Support the development and maintenance of product labeling to ensure compliance with regulatory standards.
• Collaborate with the regulatory team to conduct internal audits and ensure compliance with all applicable regulations.

2. TraceGains System Management:
• Manage and maintain the TraceGains system for supplier management, documentation, and quality control.
• Ensure that all data in the TraceGains system is accurate, up-to-date, and complete.
• Work with suppliers to gather necessary documentation and ensure compliance with company standards.
• Monitor and analyze data within the TraceGains system to identify potential risks or non-conformities.

3. Documentation and Record Keeping:
• Maintain accurate and organized records of all regulatory submissions, approvals, and communications.
• Ensure that all product specifications, ingredient lists, and labels are correctly documented in the TraceGains system.
• Assist in the development and updating of Standard Operating Procedures (SOPs) related to regulatory and TraceGains processes.

4. Regulatory Communication and Liaison:
• Communicate with regulatory agencies, as needed, to clarify requirements or address issues related to product compliance.
• Serve as a liaison between the company and external regulatory consultants or bodies.
• Coordinate with other departments to ensure that all regulatory requirements are met during product development and production.

5. Training and Support:
• Provide training and support to staff on the use of the TraceGains system and related regulatory processes.
• Assist in developing and delivering training programs on regulatory compliance and TraceGains procedures.
• Support continuous improvement initiatives within the regulatory affairs and quality assurance departments.

Qualifications:

• Bachelor’s degree in Regulatory Affairs, Food Science, Quality Assurance, or a related field.
• 2+ years of experience in regulatory affairs, quality assurance, or a related field.
• Experience with the TraceGains system or similar quality management software.
• Knowledge of FDA, USDA, and other relevant regulations.
• Strong organizational and communication skills, with attention to detail.
• Proficiency in Microsoft Office Suite and regulatory databases.

Preferred Qualifications:

• Experience in the food and beverage industry.
• Certification in Regulatory Affairs (RAC) or similar credentials.

Working Conditions:

• Primarily office-based with occasional visits to production or supplier sites.
• May require occasional evening or weekend work to meet regulatory deadlines.

Physical Requirements:

• Ability to sit or stand for extended periods.
• May require light lifting of documentation or office supplies.