ROLE SNAPSHOT

• Pay: $140,000.00 to $175,000.00
• Location/Schedule: Hybrid - Cape Coral, FL Office | Full-Time | Exempt
• Purpose: Lead enterprise-wide quality systems, regulatory affairs, and compliance while protecting product integrity, supporting business growth, and ensuring regulatory readiness across domestic and international operations.

KEY RESPONSIBILITIES

• Serve as the enterprise Quality Unit across multiple operational locations, owning the Quality Management System (QMS).
• Lead regulatory affairs and quality compliance across dietary supplements, functional foods, and cosmetic products.
• Own the Foreign Supplier Verification Program (FSVP) and maintain importer-of-record compliance.
• Lead regulatory classification decisions across dietary supplement, conventional food, cosmetic, and drug categories before import or commercialization.
• Direct compliance with DSHEA, 21 CFR 111, FSMA, 21 CFR 117, MoCRA, FDA labeling requirements, and applicable import regulations.
• Qualify, audit, and manage domestic and international contract manufacturers and quality agreements.
• Review and approve labeling, marketing materials, educational content, and commercial documentation for regulatory compliance.
• Exercise release-hold and stop-ship authority to prevent non-compliant products from launching or shipping.
• Maintain continuous inspection and audit readiness while mitigating enterprise regulatory risk.
• Provide leadership across Quality, Regulatory, Product Development, Marketing, and Commercial Operations.

MUST-HAVE QUALIFICATIONS

• Bachelor's degree in a scientific, regulatory, quality, or related discipline.
• 8-10+ years of Quality Assurance, Regulatory Affairs, and Compliance experience.
• 3-5+ years leading quality and regulatory organizations.
• Direct experience with Foreign Supplier Verification Program (FSVP).
• Working knowledge of:
• DSHEA
• 21 CFR 111
• FSMA / 21 CFR 117
• MoCRA
• FDA labeling
• USDA-APHIS
• FDA Prior Notice
• HTS Classification
• Experience qualifying and auditing domestic and international contract manufacturers.
• Experience owning enterprise Quality Management Systems.
• Experience reviewing labeling, advertising, educational materials, and marketing claims.
• Strong cross-functional leadership and communication skills.
• Experience with documentation governance systems such as DocuSign.

PREFERRED QUALIFICATIONS

• Advanced scientific or regulatory degree.
• PCQI certification.
• FSVP Qualified Individual training.
• HACCP certification.
• RAC, ASQ CQA, or CMQ-OE certification.
• Experience with animal-origin ingredients.
• Experience with liposomal, peptide, or nanoparticle products.
• Experience leading FDA inspections and audit readiness.
• Experience supporting wholesale partner compliance.

WHAT WE OFFER

• Enterprise leadership opportunity with broad organizational influence.
• High-impact role supporting innovative health and wellness products.
• Cross-functional executive collaboration.
• Opportunity to shape enterprise quality systems and regulatory strategy.
• Hybrid work environment.
• Full-time exempt position.

Honest Challenge

This is a highly accountable leadership role. You'll make difficult regulatory decisions, balance business priorities with compliance obligations, and protect the organization by maintaining rigorous quality standards.

PLEASE NOTE: While we appreciate candidates who reach out directly, given the volume, we are unable to respond to each inquiry individually.

The pay range for this position is $140,000.00 to $175,000.00. Please note that the quoted pay range for this job is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) experience, including industry or specific experience, education, knowledge, skills, and abilities, as well as internal equity, alignment with market data, and/or other applicable laws.

This position is benefits-eligible. Mercola provides competitive, affordable, and diverse benefit programs that support your total health - from a healthy body to a healthy mind. These benefits support you and your family in all aspects of life:

• Medical, Dental, and Vision coverage
• Accident, Hospital Indemnity, and Critical Illness
• Employee Assistance Program (EAP)
• Employer Paid Life and AD&D Insurance
• Optional Supplemental Life and AD&D Insurance
• Short- and Long-Term Disability Insurance
• Flexible Spending Accounts
• Health Savings Accounts
• Dayforce Wallet - get paid as you earn
• Employee Discount
• Retirement Planning (401k with matching contribution)
• Pet Insurance
• Wellness Program Offerings
• Paid Time Off, accrued per pay period based on years of service, starting at 25 days annually.
• 9 Paid Holidays per year, including 1 floating holiday.

The compensation and benefits information is accurate as of the date of this posting. The Company reserves the right to modify this information at any time, with or without notice, subject to applicable law.

The Company expects to accept applications for this position until August 16, 2026, but encourages interested applicants to apply as soon as possible. We will review this information, and one of our Talent Acquisition professionals will reach out if your background aligns with the position.