Bilingual Regulatory Technician –

7 days ago

Miramar, United States 5th HQ Full time

5th HQ - Bilingual Regulatory Technician – (cGMP / FDA Compliance) Location: Miramar, FL Schedule: Monday - Friday: 6:00am - 2:30pm Pay Rate: $20.00 - $23.00  About the Role:We are seeking a detail-oriented and highly organized Regulatory Technician to join our Quality and Compliance team. This position is responsible for ensuring compliance with FDA regulations (21 CFR Part 111) and maintaining all regulatory documentation related to the manufacturing, packaging, labeling, and holding of dietary supplements. The ideal candidate will have a strong background in technical documentation, regulatory compliance, and cGMP practices, as well as solid knowledge of quality systems in a manufacturing environment. Minimum Qualifications: Associate or Bachelor’s degree in Chemistry, Biology, Pharmaceutical Sciences, Food Science, or a related field (from the U.S. or a foreign institution). Prior experience in pharmaceutical, nutraceutical, or food manufacturing preferred. cGMP training and/or experience in a controlled manufacturing environment. Strong technical writing and communication skills (English required; bilingual a plus). Ability to manage multiple projects and meet deadlines. Proficiency in Microsoft Office (Word, Excel, PowerPoint) and familiarity with ERP systems. Key Responsibilities: Ensure compliance with FDA 21 CFR Part 111 regulations for manufacturing, packaging, labeling, and holding operations. Maintain and update all regulatory documentation, certifications, licenses, and permits. Review and approve labeling and packaging materials for regulatory compliance. Act as Regulatory Intelligence, staying current on FDA regulations and industry updates. Prepare and maintain customer quality questionnaires and technical documentation. Collaborate with management and department heads to update procedures and SOPs. Maintain and control the issuance, storage, and return of labels within the packaging department. Coordinate and conduct GMP training sessions and maintain training records. Prepare technical submissions for international product registrations. Support the management of trademarks, registrations, and patents. Why Join Us: Competitive compensation and benefits. Opportunity to grow within a regulatory and quality-driven environment. Dynamic, supportive team culture focused on compliance and excellence.

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