Job Description

Position Description:

Summary:

The Regulatory Affairs Specialist ensures compliance with applicable regulatory requirements and supports product certifications across the lifecycle of dietary supplements, from raw material review to final product labeling. This role manages documentation, regulatory submissions, certifications, and internal compliance processes to meet FDA, NSF, USDA, and customer requirements.

Key Responsibilities:

Ensure products, labels, and documentation meet applicable U.S. and global regulatory standards (21 CFR Part 111, 117, NSF 455-2, Food Safety, etc.). Review and approve product labels, marketing claims, and packaging components for regulatory and certification compliance (e.g., FDA labeling, supplement facts, structure/function claims). Prepare and maintain regulatory documentation including product ingredient master files, finished product specs, COCs, and Safety Data Sheets (SDS). Manage and coordinate product certification processes for: o USDA Organic, Non-GMO Project Verified, Vegan, Gluten-Free, Kosher, Halal, and any other product certifications Act as the primary point of contact with certification bodies (e.g., NSF, QAI, Non-GMO Project etc.) and ensure timely submission and renewal of certifications. Ensure raw materials and finished products meet certification-specific requirements, including approved sources, documentation, formulation restrictions, and labeling standards. Track and communicate changes to regulatory or certification requirements that impact formulations, processes, or labels. Participate in audits (customer, regulatory, certification) and provide documentation as the Regulatory or Certification SME. Work closely with Procurement, R&D, QA, Sales, and Production to ensure alignment with regulatory and certification objectives. Respond to internal and external inquiries related to product regulatory status or certification eligibility.

Qualifications:

Minimum of 3 years experience Bachelor's Degree Knowledge of proper cleaning techniques, procedures, and equipment. Previous experience in janitorial or custodial work preferred.

Additional Information:

Lifting, pushing, and pulling products. Ability to handle 20-25 lbs. on a frequent basis from floor to chest high. Standing for extended periods of time. Work environment may be exposed to powders, chemicals, and allergens (peanuts, tree nuts, milk, dairy, eggs, wheat, gluten, soy, fish and shellfish.) The following Regulations must be adhered to: 21 CFR 111 cGMP in Manufacturing, Packaging, or Holding Operations for Dietary Supplements FSSC 22000 Food Safety Management System 7 CFR 205 National Organic Program (NOP) Knowledge, Skills and Abilities

Shifts: Mon-Thurs 8:30 AM - 5:00 PM , Fri 8:00 AM - 2:00 PM

NutraStar is an equal opportunity employer. Employment at our Company is based solely on job-related qualifications: we recruit, hire, train, promote and compensate our employees and provide all other conditions of employment including company sponsored events without regard to race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances (referred to as protected characteristics). Employment actions are based upon our operating needs and individual employee or applicant merit, including but not limited to: qualifications, experience, ability, availability, cooperation and job performance.