10X Health System is a pioneering company in the health and wellness industry, dedicated to revolutionizing personal health and well-being. They are seeking a highly organized Regulatory Specialist to support regulatory and quality documentation operations across their supplement portfolio, ensuring compliance and maintaining audit-ready documentation.
Responsibilities
- Maintain organized files and naming conventions across supplier and product documentation folder
- Track and file GMP certificates, COAs, specifications, and other supplier documentation in accordance with 21 CFR Part 111 record-keeping standards
- Follow up with vendors and internal teams to close missing documentation and maintain version control
- Prepare documentation packages for audit, inspection, or diligence review
- Support the Director of Regulatory Affairs with day-to-day regulatory administration, including correspondence, tracking, and routing requests
- Review simple structure/function claims and marketing copy for DSHEA and FTC compliance under established templates and guidance
- Maintain and update the approved claims spreadsheet, ensuring accuracy and alignment with master approved language
- Route product and marketing assets through internal review workflows (e.g., Ziflow or shared review folders) and confirm approvals are logged
- Track completion status and archive final, approved versions
- Assist with vendor or internal inquiries related to compliance documentation
- Create and maintain trackers, logs, and summaries of outstanding requests, approvals, and follow-ups
- Prepare concise weekly reports summarizing progress, upcoming deadlines, and any blockers requiring escalation
- Schedule and document meetings, maintain task lists, and provide follow-up summaries to the regulatory and compliance teams
- Ensure consistency across all shared folders, regulatory spreadsheets, and document templates
Skills
- Strong organizational and administrative skills with attention to precision and consistency
- Working knowledge of dietary supplement regulations under DSHEA, 21 CFR 101 (labeling), and 21 CFR 111 (GMP)
- Familiarity with supplier documentation (COAs, GMP certifications, product specs) and record-keeping standards
- Clear written communication; able to draft and route concise internal correspondence
- Ability to manage repetitive, detail-oriented tasks with a high degree of accuracy
- Proactive problem-solving and timely escalation when facing incomplete or unclear information
- Comfortable working cross-functionally in a fast-paced, scaling environment with evolving systems
- 1 – 3 years of experience in regulatory affairs, quality assurance, or compliance - preferably in the dietary supplement, CPG, or wellness industry
- Experience maintaining compliance documentation, reviewing basic claims, or supporting product labeling preferred
- Understanding of FDA/FTC marketing compliance basics and supplement quality documentation
- Proficiency in Excel/Google Sheets, shared drive organization, and workflow tools (e.g., Asana)
- Associate's or bachelor's degree in a relevant scientific, legal, or health-related field
- Experience maintaining compliance documentation, reviewing basic claims, or supporting product labeling preferred
Benefits
- A comprehensive benefits package designed to support your health, well-being, and professional growth.
Company Overview
Our mission is to empower people to take control of their health and wellness journey. It was founded in 2020, and is headquartered in Aventura, Florida, USA, with a workforce of 201-500 employees. Its website is https://10xhealthsystem.com.
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