Regulatory Specialist

ABOUT 10X HEALTH SYSTEM
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. With a philosophy rooted in the principle that optimal health is the foundation for a life lived to the fullest, 10X Health provides cutting-edge solutions and personalized health plans designed to empower individuals to achieve and maintain peak physical and mental performance.

The company's comprehensive approach to health combines the latest advances in medical science, nutrition, fitness, and technology to offer a suite of services that include state-of-the-art diagnostic testing, individualized treatment protocols, and ongoing support from a team of world-class health professionals. 10X Health's commitment to innovation and results has established it as a leader in the health optimization space, catering to those who strive to push the boundaries of what is possible in their health journey.

POSITION SUMMARY
We are seeking a highly organized and detail-oriented Regulatory Specialist to support regulatory and quality documentation operations across 10X Health’s supplement portfolio. This role focuses on maintaining audit-ready documentation, routing product and marketing assets for approval, and supporting the organization of supplier and product files. The ideal candidate is process-driven, dependable, and comfortable managing administrative compliance tasks while providing accurate, timely updates to the regulatory and legal team.

This position reports to the Director of Regulatory Affairs and Corporate Counsel and will work cross-functionally with Supply Chain, Marketing, and Clinical teams to ensure compliance documentation is current, complete, and consistently organized.

OBJECTIVES
Regulatory Documentation & Operations

• 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

Claims & Label Review Support

• 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

Administrative & Cross-Functional Support

• 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

COMPETENCIES

• 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

EDUCATION AND EXPERIENCE

• 2 – 4 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

PHYSICAL REQUIREMENTS

• Prolonged periods of sitting at a desk

COMMITMENT TO DIVERSITY
As an equal opportunity employer committed to meeting the needs of a multigenerational and multicultural workforce, 10X Health System recognizes that a diverse staff, reflective of our community, is an integral and welcome part of a successful and ethical business. We hire local talent at all levels regardless of race, color, religion, age, national origin, gender, gender identity, sexual orientation, or disability, and actively foster inclusion in all forms both within our company and across interactions with clients, candidates, and partners. If you require any accommodations during the application process or have any questions, please contact [email protected].

NO SOLICITATION POLICY
10X Health does not accept unsolicited resumes, calls, or communications from staffing agencies or third-party recruiters. Any such submissions will be considered the sole property of 10X Health and will not obligate the company to pay any fees. Please refrain from contacting us regarding this posting.
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