Quality Assurance & Regulatory Compliance Specialist

Position Summary

The Quality Assurance & Regulatory Compliance Specialist ensures imported food products meet U.S. regulations and company standards. This role liaises with overseas QA personnel to ensure product safety, quality, and compliance. Additionally, the specialist collaborates with Marketing, Sales, and overseas R&D teams to manage accurate product information and maintain seamless communication.

Responsibilities

Quality Assurance & Regulatory Compliance

• Act as the primary liaison for overseas QA personnel (Japan, ASEAN) on product safety, quality, and regulatory compliance.
• Ensure products, ingredients, labels, and claims comply with FDA regulations, guidance, company standards, and industry best practices.
• Conduct quality assurance reviews on imported products and packaging, including sensory evaluations, specification verifications, and shelf-life assessments.
• Regularly visit the U.S. warehouse to monitor and evaluate product quality in coordination with the SCM department.
• Oversee FSMA compliance and respond to FDA audits and regulatory inquiries.
• Maintain and manage FSVP documentation, including the recall plan, FDA Food Facility Registration, HACCP plan, and Certificates of Analysis.
• Provide necessary food safety documentation, audit reports, and guarantee letters to distributors and customers.
• Conduct regulatory research related to CFR and other applicable food regulations.
• Stay current with FDA regulations, state requirements, and Prop 65 compliance.
• Work with external FDA and legal consultants for professional reviews, risk assessments, and compliance guidance.
• Complete the preparation of ingredient labeling and nutrition facts in compliance with U.S. regulations, and review and approve the final product labeling.
• Conduct internal audits of product labels and provide corrective action guidance.
  
  
  

Product Development Support

• Assist in new product development and reformulation projects, ensuring that ingredients, packaging, and labeling meet regulatory standards.
• Conduct sensory evaluations for product development initiatives.
• Research and monitor competitive products, industry trends, and consumer insights, focusing on ingredients, nutritional information, and claims on packaging and across all marketing channels.
  
  
  

Product Information Management

• Maintain and update product specifications to ensure accurate and accessible product data, and share up-to-date product information with internal teams, distributors, and customers.
  
  
  

Qualifications

• Bachelor’s degree in Food Science, Nutrition, Microbiology, Biology, or a related field.
• Minimum of 3 years of experience in the food industry QA, regulatory compliance, or product development.
• Preventive Controls Qualified Individual (PCQI) certification preferred (or willingness to obtain).
• Strong knowledge of FSMA, FDA food safety, and labeling regulations.
• Experience with product development processes, packaging compliance, and product information management.
• Excellent organizational skills and attention to detail in regulatory documentation and product management.
• Ability to work collaboratively with global teams and across departments.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Experience with product data platforms (e.g., One World Sync) is a plus.
• Knowledge of Japanese culture/language is a plus but not required.
  
  
  

SALARY USD 50,000-60,000

Benefits

• Health Insurance (medical, dental, vision), Life, AD&D, LTD
• Sick leave, vacation, paid holidays
• Bonus
• 401(K)
  
  
  

LOCATION Irvine , CA

WORK STYLE Hybrid work

Other Conditions

• Full-time (40 hours/week)
• Ability to lift up to 50 lbs.
• Regular food product tastings.
• Frequent video meetings in the early evening due to overseas collaboration.
• Occasional business travel (approximately 2–3 times per year).
  
  
  

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