10X Health System · 10 hours ago
Regulatory Specialist
Scottsdale, AZ
Full-time
Hybrid
Entry Level
$0/yr - $60K/yr
1+ years exp10X 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.
Health Care
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
Qualification
Required
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
Preferred
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
10X Health System
Our mission is to empower people to take control of their health and wellness journey.
201-500 employees
Funding
Current Stage
Growth StageRecent News
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