Regulatory & Quality Assurance 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

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.