Food Regulatory Affairs (RA) Specialist(English-Korean Bilingual) Functional Food & Beverage Innovation Company - 4.0 Irvine, CA Job Details Full-time $70,000 - $90,000 a year 9 hours ago Qualifications Biology Google Workspace Food allergen awareness Environmental compliance GMP Korean Bachelor's degree Food and beverage industry expertise Regulatory/legal compliance standards in production Chemistry GFSI International trade regulations Full Job Description ■ General Responsibilities Raw Material & Ingredient Regulatory Compliance Evaluate new and existing raw materials, food additives, and color additives for FDA compliance under 21 CFR and GRAS requirements. Review product formulations to ensure compliance with applicable usage limits and regulatory restrictions. Review and approve supplier technical documentation, including Product Specification Sheets, Certificates of Analysis (COAs), Safety Data Sheets (SDS), and manufacturing process flowcharts. Assess food contact substances and packaging materials for compliance with applicable FDA regulations, including BPA-Free and PFAS requirements. Product Labeling & Claims Develop and review Nutrition Facts Panels, ingredient statements, and net quantity declarations in accordance with FDA labeling requirements. Review product formulations for compliance with U.S. allergen requirements, including FALCPA and the FASTER Act. Review and substantiate nutrient content, health, and structure/function claims based on applicable regulatory requirements. Manage documentation, applications, audits, and renewals for third-party certifications such as Non-GMO, Vegan, Gluten-Free, Organic, Kosher, and Halal. Supplier & Supply Chain Compliance Manage Foreign Supplier Verification Program (FSVP) documentation, including supplier Food Safety Plans, Hazard Analyses, third-party audit reports, and cGMP compliance records. Conduct regulatory risk assessments for new ingredient suppliers and maintain qualified supplier records. Collaborate with logistics teams regarding regulatory, labeling, storage, and handling requirements for applicable food ingredients. State Regulations & Import Compliance Support California Proposition 65 compliance through chemical safety data review and exposure assessments. Monitor state-level packaging and environmental requirements, including
EPR, PFAS
restrictions, and recycling-related claims. Support U.S. import clearance activities, including FDA Prior Notice verification and technical responses related to FDA inquiries, Holds, or Import Alerts. Cross-Functional Regulatory Support Partner with R D, Quality Assurance, and Marketing teams during product development to evaluate ingredients, formulations, and regulatory requirements. Coordinate regulatory and quality requirements with U.S. co-packers and 3PL partners. Monitor FDA, USDA, and state-level regulatory developments and provide impact assessments and guidance to internal stakeholders. ■ Required Qualifications Bachelor's degree in Food Science, Food Technology, Chemistry, Biological Sciences, or a related scientific discipline. 3-6 years of experience in Regulatory Affairs, Food Compliance, or R D-integrated regulatory functions within the U.S. food or beverage industry. Strong working knowledge of FDA Food Labeling regulations (21 CFR Part 101), c
GMP/FSMA
(21 CFR Part 117), and FSVP requirements. Ability to review complex formulations, BOMs, raw material specifications, and COAs for regulatory compliance. Strong understanding of U.S. allergen regulations, including the FASTER Act, and California Proposition 65. Bilingual proficiency in English and Korean required , including professional verbal and technical written communication. ■ Preferred Qualifications PCQI (Preventive Controls Qualified Individual) or FSVP Qualified Individual certification. Regulatory experience with beverages, noodles, or shelf-stable processed foods. Experience supporting third-party certification audits, including Non-GMO or Gluten-Free certifications. Familiarity with Google Workspace, Airtable, AppSheet, or similar compliance/database management systems. ■ Physical Demands & Work Environment Ability to remain stationary and operate office equipment for extended periods. Ability to move around the work site and handle objects weighing up to 20 lbs. Flexibility to work occasional weekends, holidays, or outside normal business hours as needed. Ability to travel as business needs require. Ability to manage multiple deadlines, shifting priorities, and time-sensitive regulatory matters.
Job Type:
Full-time Pay:
$70,000.00 - $90,000.00 per year Application Question(s): Are you bilingual in Korean and English? Please specify your current status in the United States, or if you are a foreign national, indicate your visa type. Please indicate your total years of relevant experience.