Senior Regulatory Specialist

QualiTech; Chaska (MN); On-site; USD 75,000 - 97,000; Full time

Job summary

QualiTech is seeking a Senior Regulatory Specialist to work with Quality Assurance and R&D to ensure product safety and regulatory compliance for all products. The role focuses on regulatory support, product safety, and cost-reduction initiatives while aligning with QualiTech and Ellison products.

The position requires knowledge of regulatory processes, strong communication, and the ability to prepare regulatory reports and documentation.

Qualifications

• Excellent verbal and written communication skills and the ability to present information clearly.
• Strong organizational skills, including attention to detail and the ability to meet deadlines.
• Proficiency with computers and standard business software applications.
• Ability to prepare clear, accurate regulatory reports, procedures, and documentation.
• Ability to read, analyze, and interpret government regulations and industry standards.
• Flexible schedule and ability to adapt to changing priorities.

Responsibilities

• Maintain supplier and ingredient approval programs.
• Coordinate and process supplier documentation through cloud systems.
• Maintain customer documentation program and records for audits.
• Coordinate change control for formulas, labels, and specifications.
• Support regulatory records to ensure audit readiness and regulatory compliance.
• Provide technical support to R&D, Sales, and business units.
• Support compliance with SQF and BRC standards.
• Conduct traceability exercises and promote a food safety culture.

Skills

Verbal and written communication

Organization & time management

Computer proficiency

Report writing

Regulatory interpretation

Adaptability

Attention to detail

Education

High School Diploma or GED

Science-related post-secondary education preferred

Job description

The Senior Regulatory Specialist works with Quality Assurance and R&D Teams to ensure product safety and the quality of all products. This position will ensure regulatory compliance with regulatory bodies, customers and QualiTech and Ellison. Focus will be on assisting in product safety, product quality and cost reduction projects. This position requires a working knowledge of the following: Microsoft Suite, and strong knowledge of Quali-Tech and Ellison’s products. The Senior Regulatory Specialist is responsible for performing all work within established Food Safety and Quality Assurance and corporate safety guidelines.

Essential Duties and Responsibilities:

• Maintain the supplier and ingredient approval program
• Coordinate and process supplier documentation through the cloud-based supplier system
• Maintain the customer documentation program
• Coordinate change control for formulas, labels, and specifications
• Maintain regulatory records and programs to support audit readiness
• Identify and implement regulatory process improvements
• Support food safety and quality requirements
• Prepare regulatory and analytical reports
• Administer and improve the Company's Food Safety and Quality Assurance program to meet customer, regulatory, and company requirements
• Provide technical support to R&D, Sales, and business unit managers
• Support compliance with applicable third-party audit standards, including SQF and BRC
• Conduct traceability exercises
• Promote a food safety culture that reinforces food defense, quality, and cGMP requirements in production and warehousing operations
• Interpret local, federal, and international food laws
• Other duties as assigned

Qualification Requirements:

To perform this job successfully, individual must be able to perform each essential duty satisfactorily. The requirements listed below and on the physical demands sheet for this position are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and Experience:

• High School Diploma or GED required and 1-3 years’ experience in food or medical regulatory in a similar industry; Secondary education in a science related field preferred.
• A background in manufacturing and processing environments is desired.
• Previous experience with international regulations preferred.

Knowledge and Skills:

• Excellent verbal and written communication skills, with the ability to present information clearly and respond effectively to questions from customers, managers, and other stakeholders
• Strong organizational skills, including attention to detail and the ability to manage time, prioritize tasks, and meet deadlines
• Proficiency with computers and standard business software applications
• Ability to prepare clear, accurate reports, procedures, work instructions, and process documentation
• Ability to adapt promptly and effectively to changing priorities and requirements
• Ability to read, analyze, and interpret business publications, professional journals, and government regulations
• Ability to understand written instructions and complete assigned tasks and projects accurately
• Ability to work a flexible schedule based on business needs