Regulatory Compliance Manager

SUMMARY

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

Regulatory Strategy & Compliance Oversight

· 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.

Agency & Certification Management

· 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.

Product & Labeling Compliance

· 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.

Export & Global Regulatory Support

· 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.

Team Leadership & Program Governance

· 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.

DIRECT REPORTS

This role leads a team of regulatory professionals.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

EDUCATION AND EXPERIENCE

· 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.

SKILLS AND COMPETENCIES

· 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.

CERTIFICATIONS

None.

ADDITIONAL INFORMATION

WORK LOCATION

This role is expected to be onsite at our Pleasant View location in Plymouth, WI 3 days per week and may work remotely 2 days per week. Remote work must be performed within Wisconsin or another approved state in accordance with company policy.

TRAVEL REQUIREMENTS

Occasional Travel (up to 10%) – Limited travel for training, meetings, or visits to other Sartori manufacturing facilities.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by a Team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

The role requires extended periods of sitting. The role may involve lifting or carrying up to 10 pounds. The role requires repetitive hand or arm movements and sustained use of hands or arms. The role requires the ability to see details at close range and communicate verbally.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those a Team Member encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

This role is primarily performed in an office or administrative environment. The work environment is generally quiet to moderate in noise level.

The above statements are intended to describe the general nature and level of work being performed by Team Members assigned to this work. This is not an exhaustive list of all duties and responsibilities. Sartori Company reserves the right to amend and change responsibilities to meet organizational and business needs as necessary.