Regulatory Compliance Manager

Sartori Company • Plymouth, WI

8d • Hybrid

About The Position

The Regulatory Compliance Manager ensures regulatory and certification compliance across food manufacturing operations in alignment with FDA regulations, FSMA Preventive Controls (21 CFR Part 117), PMO requirements, and applicable domestic and international standards. This role provides regulatory leadership for product compliance, labeling, facility registration, certifications, and export requirements while serving as the primary liaison with regulatory agencies and certification bodies. The Regulatory Compliance Manager leads and develops a team of regulatory professionals and partners cross-functionally to support compliant product development, certifications, and operational changes.

Requirements

• Bachelor’s degree in Food Science, Chemistry, Biology, Regulatory Affairs, or a related scientific field, required.
• 5 to 8+ years of regulatory experience in a food manufacturing environment, required.
• Demonstrated working knowledge of FSMA Preventive Controls (21 CFR Part 117), required.
• Experience with PMO regulations in dairy manufacturing environments, required.
• Experience managing product certifications and claims (e.g., Non-GMO, Organic, Kosher, Halal), required.
• Experience supporting export regulatory requirements and global market access, required.
• Proven experience leading and developing regulatory or technical teams, required.
• Judgement: Forms sound opinions and make solid decisions.
• Ethical: Acts with integrity and aligns behavior to organizational values.
• Quality Commitment: Consistently strives to meet high standards of excellence.
• Collaborative: Partners with others to realize better results.
• Balances Stakeholders: Understands, anticipates, and balances the needs of multiple stakeholders.
• Coaching: Uses questions and dialogue to guide others toward solutions.
• Problem Solver: Identifies root causes and recommends effective solutions.
• Detail-oriented: Ensures accuracy and precision in work output.
• Prioritizes Effectively: Identifies and focuses on the most critical responsibilities.
• Results-driven: Focuses on achieving results that promote business success.

Responsibilities

• Ensures compliance with FDA regulations, including 21 CFR Part 117 (Preventive Controls for Human Food), food labeling requirements, and allergen control regulations.
• Ensures compliance with the Pasteurized Milk Ordinance (PMO) requirements, as applicable, and coordinates activities with state dairy regulatory authorities.
• Interprets proposed and evolving regulatory requirements, assesses business impact, and leads implementation of required changes across the organization.
• Serves as the primary liaison with regulatory agencies, including FDA and state authorities, as well as certification bodies.
• Leads preparation for, participation in, and response to regulatory inspections, audits, and inquiries.
• Oversees governance and verification of certifications and claims, including Organic, Kosher, Halal, and Non-GMO Project Verified.
• Provides regulatory leadership for product formulation, ingredient compliance, labeling, claims substantiation, and change management.
• Reviews formulations, ingredients, suppliers, labels, and process changes to ensure continued regulatory and certification compliance.
• Provides clear, risk-based regulatory guidance to internal stakeholders.
• Leads export regulatory compliance activities, including facility and process registrations for global markets.
• Partners with Sales, Marketing, Customer Service, and external organizations to support country-specific export documentation and market access.
• Oversees the annual cross-functional process for completing USMCA tariff determinations.
• Leads, mentors, and develops a team of regulatory professionals through goal setting, coaching, and performance management.
• Ensures regulatory and certification activities are appropriately resourced, prioritized, and aligned with business needs.
• Develops and maintains regulatory policies, procedures, and training programs to promote compliance and continuous improvement.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager