Regulatory Specialist

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