10X Health System is a pioneering company at the forefront of the health and wellness industry, dedicated to revolutionizing the way individuals approach their personal health and well-being. We are seeking a highly organized and detail-oriented Regulatory Specialist to support regulatory and quality documentation operations across 10X Health’s supplement portfolio.
Requirements
- 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
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Visa Sponsorship
- Four Day Work Week
- Generous Parental Leave
- Tuition Reimbursement
- Relocation Assistance
