Regulatory and Quality Specialist

Essentia Protein Solutions AB; Ankeny (IA); On-site; USD 70,000 - 90,000; Full time

Job summary

Essentia Protein Solutions AB in Ankeny, IA, seeks a Regulatory and Quality Specialist to provide timely regulatory, quality, and supplier support for Essentia North America. The role focuses on documentation, labeling submissions, and coordination with regulatory authorities.

Requirements include a Bachelor’s in Applied Sciences or an Associate with 1–3 years in regulatory/quality roles and knowledge of USDA-FSIS regulations. Strong communication and organizational skills are essential.

Qualifications

• Bachelor's degree in applied sciences or an associates degree with 1–3 years of regulatory, quality, and/or supplier experience.
• Minimum 1–3 years of work experience in regulatory affairs, quality systems, and/or supplier quality, including knowledge of USDA-FSIS regulations.
• Create and manage regulatory, quality, and supplier documentation for internal/external customers and authorities.
• Provide timely responses to customer documentation inquiries and assist with labeling submissions.

Responsibilities

• Create and manage regulatory, quality, and supplier documentation for internal/external customers and authorities.
• Provide timely responses to customer documentation inquiries, including product/site questionnaires.
• Assist with USDA and FDA labeling submissions and follow-up.
• Coordinate Organic-GAP Certifications and documentation for facilities.
• Maintain corporate controlled documentation in Colos and Reliance systems.
• Maintain accurate regulatory files and monthly reporting for Essentia North America.
• Support supplier quality projects and audits as needed.
• Review supplier assessments and update supplier records.

Skills

Regulatory knowledge

Quality systems

Supplier management

Communication skills

MS Word

MS Excel

MS Teams

USDA-FSIS regulations

Education

Bachelor's in Applied Sciences

Associates with 1–3 years experience

Tools

Colos

Reliance

Job description

Through committed service and sustainable proteins solutions, Essentia is dedicated to building a better business for our customers. We do this by holding true to our values: Teamwork, Respect, Agility, Creativity and Knowledge.

The Regulatory and Quality Specialist will provide timely and accurate regulatory, quality and supplier support for Essentia North America to help meet the needs of internal and external customers.

JOB QUALIFICATIONS

Education

Bachelor's degree in Applied Sciences, or Associates degree with 1-3 years of regulatory, quality, and/or supplier experience.

Experience

Minimum 1-3 years of work experience in a regulatory affairs role, quality systems role, and/or supply quality role, including knowledge of USDA-FSIS Regulations.

JOB DUTIES

• 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.

JOB REQUIREMENTS

• 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 daily and extended hours as needed.
• Ability to assist with special and ongoing projects as determined by leadership.
• Ability to provide assistance in other work-related areas as required.
• 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