Regulatory Affairs Specialist, Dietary Supplements & FDA Compliance
Overview
You will own regulatory compliance for dietary supplement products at DrVita, Inc., ensuring adherence to FDA regulations, DSHEA, and 21 CFR Part 111 cGMP requirements. Collaborate with R&D, Quality, and Marketing to review labels, claims, and documentation. You will drive audit readiness and continuous improvement in a GMP-regulated facility. This role offers a stable schedule and a benefits package including 401(k) match and wellness perks.
What You'll Do9
- 1Ensure compliance with FDA, DSHEA, and 21 CFR Part 111 cGMP requirements across all product lines.
- 2Review product labels, Supplement Facts panels, ingredients, and marketing claims for regulatory accuracy.
- 3Evaluate regulatory risks for new products, formulations, and ingredients, and provide mitigation strategies.
- 4Maintain regulatory SOPs, product specifications, SDS files, and controlled documentation.
- 5Support Document Control and Change Control activities to ensure traceability and compliance.
- 6Complete customer regulatory questionnaires and documentation requests within 3-5 days.
- 7Support regulatory, customer, and third-party certification audits, including NSF, USP, Organic, Non-GMO, Kosher, and Halal.
- 8Assist with registrations, licenses, corrective actions, and regulatory inspections.
- 9Provide regulatory guidance to R&D, Quality, Marketing, and other departments.
Requirements7
- 13-5 years of regulatory, quality, or compliance experience in a regulated manufacturing environment.
- 2Bachelor's degree in Regulatory Affairs, Food Science, Biology, Chemistry, Life Sciences, or related field preferred.
- 3Knowledge of FDA dietary supplement regulations, DSHEA, and 21 CFR Part 111.
- 4Experience with dietary supplement labeling and claims preferred.
- 5Strong technical writing, organization, analytical, and communication skills.
- 6Proficiency with Microsoft Office and electronic document or quality management systems.
- 7Experience with NSF, USP, Organic, Non-GMO, Kosher, or Halal certifications is a plus.
Salary Insight
$72 - $76k per year
Location
Required Skills
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