Food Regulatory Affairs (RA) Specialist

HYH America Inc. is a U.S.-based subsidiary of hy Co., Ltd., a South Korean leader in fermented dairy, functional beverages, and health-focused nutrition with over 50 years of innovation. Building on hy's legacy of pioneering wellness solutions for millions of households, HYH America represents the company's strategic expansion into the United States market. More than a product-driven business, HYH America is a purpose-led venture committed to shaping everyday lifestyles. Our mission is to inspire Healthier Habits and Happier Cultures, bringing together thoughtfully crafted wellness products, community, and cultural experiences to create a more balanced and joyful way of living. Through health innovation, authentic collaborations, and culturally relevant engagement, HYH America is redefining how wellness is experienced across America and beyond. JOB OVERVIEW We are seeking a detail-oriented and experienced Food Regulatory Affairs (RA) Specialist to oversee and execute regulatory compliance for our food and beverage product portfolio distributed across the United States. This role is responsible for the full lifecycle of regulatory compliance, including raw material and ingredient validation, formulation review, FDA/USDA labeling compliance, FSVP supplier verification, third-party clean-label certifications, and state-level chemical/environmental regulations. The Specialist will serve as a key regulatory liaison between headquarters, local US operations, co-packers, and supply chain partners. This is a fulltime, exempt position, fully on-site based at our Irvine, CA office. ROLES AND RESPONSIBILITIES Raw Material & Ingredient Regulatory Compliance Evaluate new and existing raw materials, food additives, and color additives for FDA compliance under 21 CFR (Direct/Indirect Additives) and GRAS (Generally Recognized as Safe) status. Conduct technical reviews of formulations, monitoring usage limits and restrictions for raw materials. Audit and approve technical dossiers from domestic and international suppliers, including Product Specification Sheets, Certificates of Analysis (COAs), Safety Data Sheets (SDS), and Manufacturing Process Flowcharts. Assess food contact substances (FCS) and primary/secondary packaging materials (cans, pouches, films, closures) for compliance under 21 CFR Parts 174–178, verifying BPA-Free status and PFAS restrictions. Product Labeling & Claims Substantiation Develop and approve Nutrition Facts Panels, standardized ingredient statements (ordered by predominance), and net quantity statements in compliance with FDA 21 CFR Part 101. Audit product formulations for allergen compliance under the FALCPA and FASTER Act (all 9 major US allergens), assessing cross-contact risks and reviewing advisory labeling. Substantiate marketing and product claims, including Nutrient Content Claims, Health Claims, and Structure/Function Claims, ensuring adequate scientific and legal documentation. Lead the documentation, application, audit support, and renewal processes for third-party certifications, such as Non-GMO, Vegan, Gluten-Free, Organic (USDA NOP), and Kosher/Halal. Supply Chain Verification & Supplier Compliance (FSMA/FSVP) Manage Foreign Supplier Verification Programs (FSVP) by collecting, evaluating, and maintaining supplier Food Safety Plans, Hazard Analyses, third-party audit reports, and cGMP (21 CFR Part 117) compliance records. Conduct regulatory risk assessments for new ingredient vendors and maintain qualified supplier databases. Collaborate with logistics teams to evaluate regulatory, labeling, and storage requirements for hazardous or dangerous goods (DG Class) food ingredients handled at 3PL warehouses. State Regulations & Import Compliance Monitor chemical safety data (heavy metals, processing by-products like acrylamide) to manage California Proposition 65 compliance, performing exposure assessments and determining warning label requirements. Track emerging state-level packaging and environmental regulations, including Extended Producer Responsibility (EPR), PFAS bans, and recycling claims (How2Recycle). Support import clearance processes, assisting with FDA Prior Notice verifications and drafting technical response packages for FDA inquiries, Holds, or Import Alerts. Cross-functional Collaboration & Regulatory Monitoring Partner closely with R&D, Quality Assurance, and Marketing teams during the early stages of product development to screen ingredients and optimize formulas against regulatory constraints. Coordinate regulatory requirements and quality standards with local US co-packers and 3PL warehousing partners. Monitor proposed and finalized FDA, USDA, and state food regulations, preparing impact assessments and operational guidance for internal stakeholders. QUALIFICATIONS Required Qualifications Education : Bachelor’s degree in Food Science, Food Technology, Chemistry, Biological Sciences, or a related scientific discipline. Experience : 2+ years of hands‑on Regulatory Affairs, Food Compliance, or R&D‑integrated regulatory experience within the US food/beverage industry. Technical Expertise: In‑depth working knowledge of FDA Food Labeling regulations (21 CFR 101), cGMP/FSMA (21 CFR 117), and FSVP requirements. Demonstrated ability to analyze complex formulation batch sheets (BOMs), raw material specs, and COAs for regulatory bottlenecks. Comprehensive understanding of US allergen laws (FASTER Act) and California Proposition 65 assessment. Language Proficiency : Bilingual in English and Korean (professional verbal and technical written fluency required for liaising with overseas headquarters and US regulatory bodies/partners). Preferred Qualification PCQI (Preventive Controls Qualified Individual) or FSVP Qualified Individual certification. Experience managing regulatory reviews for complex formulations in beverages (RTD, carbonated), noodles, or shelf‑stable processed foods. Hands‑on experience with third‑party certification audits (e.g., SCS Global Non‑GMO, GFCO Gluten‑Free). Familiarity with productivity and database systems (Google Workspace, Airtable, AppSheet) for managing compliance registries. PHYSICAL DEMANDS & WORK ENVIRONMENT Must be able to remain in a stationary position and operate office equipment for a prolonged period. Physical activities include, but are not limited to, constant manual dexterity, moving about the work site, and/or handling objects weighing up to 20 lbs. Must be able to work a schedule that supports business operations, including occasional weekends, holidays, and hours outside of the normal work schedule, as needed. Must be able to travel as business needs require. Must be able to handle multiple deadlines, shifting priorities, and time-sensitive issues. Requires strong attention to detail, professionalism, and effective collaboration with internal teams and external partners. Equal Opportunity Statement HYH America is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. The pay range for this role is: 70,000 - 90,000 USD per year (HYH America - Irvine) #J-18808-Ljbffr