Food Regulatory Affairs; RA) Specialist

HYH America Irvine, California, United States

About HYH America

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 (How2
  
  Recycle).
• 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…