Regulatory Specialist, Claims Review

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 detail-oriented Regulatory Specialist to support product and marketing claims compliance across dietary supplements, wellness products, and related offerings. This role is responsible for executing structured claims review processes, maintaining substantiation documentation, and ensuring alignment with FDA, FTC, and applicable state-level advertising and labeling requirements.

This position plays a critical role in supporting the regulatory function by managing high-volume, day-to-day claims review activities, enabling the broader regulatory and legal teams to focus on strategic initiatives, risk management, and regulatory expansion. The ideal candidate is process-driven, highly organized, and able to operate efficiently within established compliance frameworks while escalating higher-risk issues appropriately.

OBJECTIVES
Claims Review & Substantiation Support

• Review product, website, and marketing claims against internal guidelines and substantiation standards
• Verify alignment of claims with approved language, supporting evidence, and regulatory requirements
• Identify and flag high-risk or non-compliant claims for escalation to senior regulatory or legal leadership
• Assist in maintaining consistency across product claims, marketing assets, and supporting documentation

Regulatory Documentation & File Management

• Organize and maintain claims substantiation files, including scientific references, summaries, and internal approvals
• Maintain documentation related to product specifications, certificates of analysis, and formulation details as they relate to claims support
• Ensure documentation is audit-ready and aligned with internal quality and compliance expectations
• Support internal audits, documentation reviews, and regulatory readiness initiatives

Cross-Functional Support & Communication

• Serve as a point of contact for marketing and cross-functional teams on claims-related questions
• Provide approved language and ensure consistency in claim usage across channels
• Respond to internal requests in a timely manner while adhering to established review processes
• Coordinate with regulatory, legal, and product teams to ensure alignment on claims-related decisions

Tracking, Reporting & Process Adherence

• Track key metrics including volume of claims reviewed, turnaround time, and escalation rates
• Maintain logs of reviewed assets and associated determinations
• Support continuous improvement of claims review workflows and documentation practices
• Adhere strictly to established SOPs, templates, and regulatory review processes

COMPETENCIES

• Strong attention to detail and ability to review content against defined standards
• Ability to follow structured processes and maintain consistency across high-volume reviews
• Foundational understanding (or ability to learn) of FDA/FTC requirements for dietary supplements and advertising
• Ability to identify potential regulatory risk and escalate appropriately
• Strong organizational and documentation management skills
• Effective written and verbal communication skills
• Comfortable working in a fast-paced, high-growth environment with evolving priorities

EDUCATION & EXPERIENCE

• Bachelor’s degree or equivalent work experience
• 1–3 years of experience in regulatory, quality, compliance, or related operational roles strongly preferred
• Experience in dietary supplements, food, cosmetics, or health/wellness industries is a plus
• Exposure to claims review, labeling, or marketing compliance processes preferred
• Experience working with document management systems or asset review platforms is a plus

PHYSICAL REQUIREMENTS

• Prolonged periods of sitting at a desk
• Must be able to lift up to 15 pounds at times

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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