Regulatory and Quality Specialist - Essentia

Essentia Protein Solutions is hiring a Regulatory and Quality Specialist to provide timely and accurate regulatory, quality, and supplier support for Essentia North America. The role supports customer documentation, regulatory compliance and labeling, controlled records, supplier assessments, and supply-chain quality activities.

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Responsibilities

• Create and manage regulatory, quality, and supplier documentation as required by internal/external customers, third party organizations, and local government agencies (USDA, FDA, Import/Export, etc.)
• Provide timely and accurate responses to customer documentation inquiries, including product and site questionnaires and other collateral documents
• Assist with USDA and FDA labeling submissions and follow-up
• Help research appropriate USDA/FDA regulations and work with Regulatory and Quality Managers to provide feedback to internal and external customers
• Coordinate Organic-GAP Certifications, including support to manufacturing facilities with documentation needed
• Maintain corporate controlled documentation, including regulated labeling systems within Colos and Reliance software systems
• Maintain accurate, up-to-date records, including monthly reporting and regulatory files for Essentia North America
• Support customer service and supplier quality projects with documentation where needed
• Assist with processing of professional membership renewals and registrations for Essentia North America
• Review and manage Harmonized Tariff Schedule codes and create documentation for their selection
• Perform vendor site assessments to deploy risk management techniques for suppliers. Monitor poor performance or otherwise that negatively impact quality and delivery metrics
• Perform on-site inspections with warehouse entities where applicable
• Coordinate with supply chain management on completion of specification and quality agreements with suppliers
• Reviews and coordinates all aspects of the supplier assessment process
• Provides updates to supplier records on behalf of account owners
• Assist corporate supply chain management with supplier data for metrics and risk management documents. This includes audits, complaints, and receiving inspections
• Coordinate Essentia activities around supplier expectations
• All other tasks as assigned

Qualifications

• Bachelor's degree in Applied Sciences, or Associates degree with 1-3 years of regulatory, quality, and/or supplier experience
• Minimum 3-5 years of work experience in a regulatory affairs role, quality systems role, and/or supply quality role, including knowledge of USDA-FSIS Regulations
• Knowledge of organizational methods and ability to work in a fast pace changing environment and manage multiple tasks simultaneously
• Proficient English skills
• Knowledge and ability to communicate effectively with corporate staff, manufacturing staff, and Essentia customers
• Competent in the use of computers and software packages such as MS Word, Excel, PowerPoint, Reliance, MS Teams
• Strong attention to detail
• Ability to communicate and interact in a professional manner that upholds the Essentia Values
• Ability to work with international trade of food and/or regulated feed, fertilizer and petfood ingredients (IDALS, AAFCO, APHIS, CFIA etc.)
• Raises vital questions and problems, formulation them clearly and precisely
• Gathers and assesses relevant information, using abstract ideas to interpret it effectively comes to well-reasoned conclusions and solutions, testing them against relevant criteria and standards
• Proliant is the world's largest and most experienced manufacturer of animal-derived proteins, producing a variety of grades of Fraction V Bovine Serum Albumin (BSA).
• Ankeny, Iowa, USA
• https://phb1.com
• Growth Stage
• Leadership Team
• Christopher Detzel
• President/CEO
• Recent News
• Research and Markets
• Plasma Protein Powder Industry Analysis 2025: Regional Market Opportunities, Strategies of Key Companies
• 2025-07-15
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Required skills

• International Trade in Food and Regulated Ingredients, Microsoft Excel, Microsoft PowerPoint, Microsoft Teams, Microsoft Word, Quality Systems, Regulatory Affairs, Reliance, Supply Quality, USDA-FSIS Regulations

Experience

• 3-5 years