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Label Compliance Specialist

Health Genesis Corp -
Davie, FL

Quick Apply

Job Details

Full-time

Benefits

Health insurance
Dental insurance
Paid time off
Vision insurance
Employee discount
Life insurance
Referral program

Qualifications

Customer communication
Regulatory compliance projects
Research
Data-driven problem-solving
FDA regulations

Full Job Description

Overview

Health Genesis, located in Davie, FL, is a manufacturer and distributor of vitamins, minerals, superfoods, and supplements. Our Mission is to favorably contribute to nutrition and health through the development, production, and marketing of natural products with the utmost quality. The company is looking for an experienced, talented individual to function as Label Compliance Specialist.

Job Purpose: Ensures that product labels, formulas, claims, comply with applicable dietary supplement and nutraceutical regulations, supporting project execution in accordance with 21 CFR 111, 101, FDA, NSF, CCOF, Kosher, other regulatory agencies, and internal policies.

Essential Duties:

Review and approve product labels, supplement facts, ingredient statements, and claims per 21 CFR 111, 101, FDA, NSF, CCOF, Kosher, other regulatory agencies, and internal policies.
Conduct regulatory assessments for new products, formula changes, and reformulations.
Provide guidance on acceptable claims, warnings, allergen statements, and country-specific requirements.
Act as primary liaison with clients for label compliance and documentation.
Prepare and maintain technical product files (CoA, SDS, allergen, non-GMO, organic, gluten-free, etc.).

Lead the product specifications, new company/ product certifications, such as Organic, vegan, Non GMO.
Support regulatory submissions, audits, QA/QC documentation, CAPAs, and risk assessments.
Coordinate internally with QA/QC, R&D, product development, procurement, and production to ensure project alignment.
Collaborate with design team to ensure artwork regulatory accuracy, formatting, and disclaimers.
Support formulation reviews, raw material qualification, and claim substantiation.
Research new regulations and market trends affecting product development.
Maintain regulatory documentation systems and databases.

Provide customer support related to regulatory questions and product documentation.

Coordinate with the client for them to send letters to the FDA related to label compliance.

Direct duties related to label compliance with Prop 65.

Qualifications and Personality Profile:

· Demonstrates proficiency in applicable cGMP regulations and dietary supplement regulatory frameworks.

· Able to prioritize and manage workload effectively, shifting priorities as needed to ensure QA/QC, regulatory, and production needs are met within critical deadlines.

· Skilled at reading, analyzing, and interpreting complex technical documents, including scientific literature, regulatory guidance, and product specifications.

· Adept at collecting data, establishing facts, analyzing evidence, defining problems, and drawing valid, supportable conclusions.
Demonstrates strong scientific and technical writing skills.

· Possesses excellent interpersonal skills; self-motivated with a positive, constructive attitude.

· Extremely detail-oriented and organized, with excellent communication capabilities and administrative discipline.
Demonstrates mentoring, coaching, and teaching abilities to support cross-functional stakeholders.

· Strong problem-solving, judgment, and decision-making abilities, with the ability to assess risk and propose effective solutions.
Effective written, verbal, and presentation communication skills tailored to technical and non-technical audiences.

· Proficient in ERP and EQMS systems, Microsoft Office, and Adobe Acrobat.

· Agile learner who readily adapts to evolving regulatory, organizational, and market requirements.

· Advanced project-management skills, including planning, execution, and timeline management. Advanced research and analytical reasoning skills to support regulatory decisions and product development.

· Advance with AI-assisted tools to support regulatory research, label review, and documentation accuracy.
Maintains a customer-centered mindset when supporting internal and external clients.

· Communicates regulatory requirements clearly and respectfully, offering guidance and solutions.

· Demonstrates responsiveness, professionalism, and a collaborative approach when handling customer requests, documentation needs, or product-related inquiries.

Job Type: Full-time

Benefits:

Dental insurance
Employee discount
Health insurance
Life insurance
Paid time off
Referral program
Vision insurance

Work Location: In person

Quick Apply

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