Regulatory Specialist

Required Skills & Experience

Required Qualifications Bachelor's degree in a science-related field, with Chemistry, Biology, or Engineering preferred 1 to 3 years of regulatory compliance experience

Experience within an FDA-regulated industry, such as:

Cosmetics Pharmaceuticals Medical devices Food Excellent attention to detail Strong written and verbal communication skills Ability to learn and navigate computer-based systems Ability to maintain accuracy during high-volume administrative work Ability to work onsite in Omaha Comfortable working at a computer for extended periods

Nice to Have Skills & Experience

Preferred Experience Personal care products Cosmetics Pet care products Household or industrial products Regulatory or legal documentation Chemistry or scientific methods Basic laboratory skills PLM systems UL WERCSmart Product registration Formula and raw-material review Supplier regulatory documentation

Job Description

We are seeking a Regulatory Specialist to provide regulatory support for product development and ongoing compliance activities within a consumer products manufacturing environment. The Regulatory Specialist will work extensively with product and formula data, raw materials, regulatory documentation, packaging information, suppliers, and product registrations. This person should be highly detail-oriented and comfortable spending substantial portions of the workday reviewing and maintaining information within computer systems.

Responsibilities

Enter, review, and analyze information within the Product Lifecycle Management (PLM) system Review product formulas and raw materials for regulatory compliance Interpret applicable regulatory requirements Review digital artwork for primary and secondary packaging Prepare documentation required for product registrations

Prepare regulatory documentation, including:

Good Manufacturing Statements Certificates of Free Sale Regulatory packets Compile existing documentation for customer requests Assist with documentation for EU Product Information Files (PIFs) Submit product information through the UL WERCSmart Manufacturer Portal Communicate with raw-material suppliers to obtain regulatory information Evaluate alternative chemical suppliers Enter and review formulas within company systems Maintain accurate regulatory documentation and files Support chemists through formula reviews, regulatory interpretation, and raw-material evaluation when appropriate Maintain reliable attendance and meet onsite work requirements

Working Environment Primarily an office-based, climate-controlled environment Occasional exposure to warehouse or manufacturing environments that may include temperature changes, dust, noise, and wet conditions Travel expectations of up to 10% annually