Regulatory and Quality Specialist - Essentia

Lauridsen Group•Ankeny, IA

About The Position

The Regulatory and Quality Specialist provides timely and accurate regulatory, quality, and supplier support for Essentia North America, helping meet the needs of internal and external customers. The role creates and manages regulatory, quality, and supplier documentation; supports customer inquiries, regulatory submissions, certifications, and supplier quality activities; and maintains corporate records and controlled documentation. It also coordinates supplier assessments and risk-management activities, supports international trade compliance for food and regulated ingredients, and may travel up to 25%.

Requirements

Bachelor's degree in Applied Sciences, or an associate degree with 1–3 years of regulatory, quality, and/or supplier experience.
3–5 years of work experience in regulatory affairs, quality systems, and/or supply quality, including knowledge of USDA-FSIS regulations.
Knowledge of organizational methods and ability to work in a fast-paced, changing environment while managing multiple tasks.
Proficient English skills.
Ability to communicate effectively with corporate staff, manufacturing staff, and Essentia customers.
Competence with computers and software packages such as MS Word, Excel, PowerPoint, Reliance, and MS Teams.
Strong attention to detail.
Ability to communicate and interact professionally in a manner that upholds Essentia values.
Ability to work daily and extended hours as needed.
Ability to assist with special and ongoing projects and provide assistance in other work-related areas as required.
Ability to work with international trade of food and/or regulated feed, fertilizer, and pet food ingredients, including IDALS, AAFCO, APHIS, and CFIA requirements.
Ability to raise vital questions and problems clearly and precisely; gather and assess relevant information; interpret it effectively; reach well-reasoned conclusions and solutions; and test them against relevant criteria and standards.
Willingness to travel up to 25%.

Responsibilities

Create and manage regulatory, quality, and supplier documentation for internal and external customers, third-party organizations, and government agencies, including USDA, FDA, and import/export authorities.
Respond to customer documentation inquiries, including product and site questionnaires and collateral documents.
Assist with USDA and FDA labeling submissions and follow-up.
Research USDA and FDA regulations and work with Regulatory and Quality Managers to provide feedback to internal and external customers.
Coordinate Organic-GAP certifications and support manufacturing facilities with required documentation.
Maintain corporate controlled documentation, including regulated labeling systems in Colos and Reliance.
Maintain accurate, current records, including monthly reports and regulatory files for Essentia North America.
Support customer service and supplier quality projects with documentation.
Assist with professional membership renewals and registrations for Essentia North America.
Review and manage Harmonized Tariff Schedule codes and create documentation supporting code selection.
Perform vendor site assessments and apply supplier risk-management techniques.
Monitor supplier performance issues that negatively affect quality and delivery metrics.
Perform on-site inspections with warehouse entities when applicable.
Coordinate with supply chain management to complete supplier specifications and quality agreements.
Review and coordinate all aspects of the supplier assessment process.
Update supplier records on behalf of account owners.
Assist corporate supply chain management with supplier data for metrics and risk-management documents, including audits, complaints, and receiving inspections.
Coordinate Essentia activities related to supplier expectations.
Perform other tasks as assigned.