Keiko Food Corp. Regulatory Assistant

Keiko Food Corp.

HK$2.1-2.8K[月薪]

现场办公 - 達義1-3 年經驗本科全職

Prepare and submit LTO applications (initial, renewal, or variation) through the FDA ePortal
Compile and submit complete CPR dossiers in compliance with FDA AO 2014-0029 and relevant regulations
Coordinate with third-party laboratories for product testing (e.g., microbiological, physico-chemical)
Monitor application status via FDA eServices and respond to FDA queries or deficiencies
Maintain an updated compliance tracker for LTO and CPR expirations, renewals, and ongoing applications.
Ensure that product labels, inserts, and promotional materials comply with FDA regulations
Liaise with regulatory bodies such as BAI (for animal products), DA, or DOH as needed
Assist in FDA inspections, audits, and document control for quality management

Bachelor’s degree in Food Technology or related field
At least 1 yr of hands-on experience in FDA product registration and LTO process
Strong knowledge of FDA Circulars, AO and e-portal submission system
Familiarity with product classification, risk categories and labeling standards
Excellent documentation, communication, and organizational skills
certification in HACCP, GMP, Halal is an advantage

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