Senior Regulatory Specialist
About the role
The Senior Regulatory Specialist works with Quality Assurance and R&D teams to ensure product safety and the quality of all products. This position ensures regulatory compliance with regulatory bodies, customers, QualiTech, and Ellison. The focus is on assisting in product safety, product quality, and cost‑reduction projects while operating within established Food Safety, Quality Assurance, and corporate safety guidelines. Required working knowledge includes Microsoft Suite and a strong understanding of Quali‑Tech and Ellison’s products.
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.
- Perform other duties as assigned.
Qualifications
To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and Experience
- High School Diploma or GED required.
- 1–3 years’ experience in food or medical regulatory roles in a similar industry.
- Secondary education in a science‑related field preferred.
- Background in manufacturing and processing environments desired.
- Previous experience with international regulations preferred.
Knowledge and Skills
- Excellent verbal and written communication skills; ability to present information clearly and respond effectively to customers, managers, and other stakeholders.
- Strong organizational skills, attention to detail, and 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.
- Willingness to work a flexible schedule based on business needs.