Regulatory Compliance Specialist

Regulatory Compliance Specialist

Orem, Utah

The Company

At Bucked Up, we’re more than a supplement company—we’re a lifestyle brand on a mission to empower individuals to achieve their fitness and health goals. As one of the fastest-growing supplement brands, we’re known for pushing boundaries and creating bold, innovative products. To keep up with our momentum, we’re looking for a persuasive, results-driven Regulatory Compliance Specialist to join our team and take our marketing to the next level.

Overview

We are seeking a highly skilled and detail-oriented Regulatory Compliance Specialist to join our team in ensuring that all product labels, marketing materials, and promotional content for our nutritional supplements comply with FDA regulations. This position is crucial to our commitment to quality and consumer safety. The ideal candidate will have a strong understanding of FDA guidelines, particularly regarding structure-function claims and scientific substantiation of product claims.

As a Compliance Specialist, you will review and analyze nutritional supplement labels and related marketing materials to ensure they meet legal and regulatory standards. You will be responsible for verifying that all claims made about active ingredients are backed by scientific evidence and in full compliance with federal regulations.

Responsibilities:

• Label and Marketing Material Review:
  • Review product labels, packaging, and marketing materials to ensure compliance with FDA regulations, including the Dietary Supplement Health and Education Act (DSHEA), 21 CFR, and other applicable laws.
  • Ensure that all claims made (e.g., structure-function claims, health claims, nutrient content claims) are substantiated by scientific evidence and appropriately worded to avoid misbranding.
• Scientific Substantiation:
  • Identify and analyze relevant scientific studies to substantiate all claims about active ingredients in the products.
  • Collaborate with internal teams (e.g., R&D, Marketing, and Legal) to ensure the claims are both accurate and compliant.
  • Maintain a database of credible and current scientific research to support ongoing compliance.
• Regulatory Guidance and Interpretation:
  • Provide regulatory guidance to internal stakeholders, including product development, marketing, and legal teams.
  • Stay current with FDA regulations, updates, and industry trends regarding dietary supplements and food labeling.
• FDA and Regulatory Reporting:
  • Assist in preparing documentation and reports required for FDA submissions or audits.
  • Ensure that products meet all FDA guidelines regarding structure-function claims, ingredient disclosures, and other applicable regulations.
• Continuous Education and Training:
  • Educate internal teams on FDA regulations, labeling standards, and industry best practices.
  • Participate in industry webinars, seminars, and conferences to stay updated on regulatory changes.

Skills and Qualifications:

• Knowledge:
  • In-depth knowledge of FDA regulations regarding dietary supplements, especially structure-function claims and labeling requirements.
  • Familiarity with DSHEA, 21 CFR 101, 21 CFR 111, and other relevant FDA guidelines.
  • Strong understanding of scientific research and the ability to evaluate studies for substantiating product claims.
• Skills:
  • Strong attention to detail and excellent analytical skills.
  • Ability to interpret complex regulatory requirements and communicate them effectively to cross-functional teams.
  • Excellent written and verbal communication skills.
  • Proficiency with regulatory databases, Microsoft Office Suite, and industry-specific compliance tools.
  • Certifications: Regulatory affairs or compliance certification (e.g., RAC, SQF) is a plus.
  • Experience with FDA inspections or audits is highly desirable.
  • Knowledge of other industry standards (e.g., NSF, USP, GMP) is a plus.

Education & Experience

• Education: Bachelor’s degree in a related field (e.g., Food Science, Nutrition, Regulatory Affairs, Life Sciences, or similar).
• Experience: At least 3 years of experience in regulatory compliance, quality assurance, or a related field in the dietary supplement industry.

What We Offer:

• Competitive salary and performance bonuses.
• Opportunity to grow with one of the fastest-growing brands in the fitness industry.
• A collaborative, energetic work environment that celebrates innovation.
• Discounts on all Bucked Up products.
• Benefits