Regulatory Manager

ESSENTIAL FUNCTION:

As a member of the Quality Team at Medtrition (the “Company”), the Regulatory Manager (“RM”) will have a pivotal role in ensuring our products meet all applicable FDA, USDA, and international regulatory standards, while also managing the accuracy and compliance of product labeling and regulatory documentation. The ideal candidate will bring strong experience in food and dietary supplement compliance, quality systems, and cross-functional collaboration.

The RM plays a dynamic role overseeing Medtrition’s regulatory compliance program across the company’s product portfolio, ensuring products, labels, claims, ingredients, packaging, and supporting documentation comply with applicable U.S. and International regulatory requirements. He/she will serve as the primary regulatory subject matter expert and cross-functional partner to Quality, R&D, Sales, Marketing, Operations, and external manufacturing partners, helping to maintain the highest standards of product excellence. This role will report directly to the Senior Director of Quality, Regulatory, and R&D.

Culture at Our Core: At Medtrition, we are committed to developing safe, effective, and compliant medical food products that make a meaningful difference in patient care. As a fast-growing leader in medical nutrition, we operate at the intersection of food science and healthcare, driven by a mission to deliver trusted solutions that improve lives.

Medtrition is a rapidly growing company guided by 20 core principles that shape the actions we take and decisions we make every day. The RM position offers an exciting opportunity to join our Quality team and play a key role support our customers, business activities, and external contract manufacturers while helping protect and strengthen the Medtrition brand through regulatory excellence.

Regulatory Compliance & Oversight: The RM owns and oversees regulatory compliance across Medtrition’s product portfolio and business activities. The RM interprets and applies applicable FDA, USDA, medical food, dietary supplement, food, labeling, and international regulatory requirements to ensure ongoing compliance. The RM monitors changes in regulations, guidance, standards, and industry expectations and assesses their potential impact on Medtrition products, operations, and business activities.

Regulatory Risk Management: The RM identifies and evaluates potential regulatory risks and provides recommendations to mitigate those risks. The RM supports regulatory investigations, customer inquiries, audits, regulatory inspections, and other compliance-related activities as needed, ensuring appropriate documentation and follow-through.

Documentation Management: The RM establishes and maintains organized, accurate, and current regulatory files for Medtrition’s product portfolio. This includes collaborating with contract manufacturers, suppliers, and other external partners to obtain and maintain current documentation related to audits, ingredients, specifications, certifications, and other regulatory requirements. The RM prepares and provides required documentation for international registrations and partners closely with the International team to ensure regulatory dossiers are accurate, complete, and compliant with the requirements of each country of registration.

Product & Label Compliance: The RM leads the regulatory review and approval of new and existing product labels across Medtrition’s frozen and medical food product lines. The RM ensures product labels, claims, artwork, packaging, and other consumer-facing materials are accurate and comply with applicable regulatory requirements. The RM maintains organized and controlled records of final approved label files and supporting regulatory documentation.

Cross-Functional Partnership: The RM serves as a regulatory subject matter expert and partners closely with departments including International, Marketing, R&D, Quality, and Sales to provide regulatory guidance, evaluate product and business initiatives, and ensure appropriate substantiation for claims and other regulatory requirements. The RM works collaboratively across functions to identify regulatory considerations early and develop practical, compliant solutions that support Medtrition’s business objectives.

Process Improvement: The RM partners with the Quality team to establish, maintain, and continuously improve formal policies, procedures, and processes related to regulatory compliance for both internal teams and external stakeholders. The RM identifies opportunities to optimize and standardize regulatory processes, improve documentation and communication, and increase operational efficiency as Medtrition continues to grow.

Contract Manufacturer Regulatory Oversight: The RM provides regulatory oversight and guidance to Medtrition’s external contract manufacturing and supplier partners. The RM reviews regulatory documentation, specifications, proposed product or process changes, and other compliance-related information to ensure external partners maintain alignment with Medtrition’s regulatory requirements. The RM collaborates with Quality and external partners to identify and resolve regulatory gaps and ensure changes are appropriately evaluated, documented, and implemented.

The Regulatory Manager is a key member of Medtrition’s Quality team and serves as the primary regulatory subject matter expert for the organization. This role owns regulatory compliance across Medtrition’s products and business activities while providing strategic guidance to internal teams and external partners. The RM is responsible for regulatory documentation, product and label compliance, international regulatory support, regulatory risk management, and continuous process improvement. Through strong regulatory oversight and cross-functional partnership, the RM helps protect the Medtrition brand, maintain product integrity, and support the company’s continued growth.

DUTIES AND RESPONSIBILITIES

• Ensure compliance with FDA, USDA, and international food regulations, including 21 CFR, FSMA, EFSA, and other applicable standards.
• Prepare, maintain, and update regulatory documentation, including finished product specifications, ingredient specifications, SOPs, etc.
• Oversee the development and review of product labels to ensure compliance with regulatory requirements (e.g., ingredient declarations, allergen labeling, Nutrition Facts panels, and claims substantiation).
• Partner with R&D and Marketing teams during product development to proactively address regulatory risks and ensure accurate labeling and claims substantiation.
• Monitor changes in state, federal, and international food regulations, and communicate updates and impact assessments to internal stakeholders.
• Review all website and digital marketing content to ensure regulatory compliance.
• Support product complaints and quality issues, lead root cause analyses, and implement effective corrective actions.
• Manage internal systems and customer-facing databases to maintain up-to-date, compliant product information.
• Lead the preparation, submission, and maintenance of international registration dossiers and global regulatory documentation.

ESSENTIAL SKILLS NEEDED:

• Strong understanding of FDA labeling regulations (21 CFR), USDA-FSIS policies, HACCP, GMP, and PCQI requirements.
• Experience with USDA label submissions and FDA-compliant product packaging.
• Skilled in interpreting complex regulatory requirements and applying them in a manufacturing environment.
• Proficiency in Microsoft Office Suite (required) and Adobe platforms (preferred).
• Well-rounded, team-oriented personality with strong problem solving and time management skills.
• Exceptionally detail-oriented and organized, with strong written and verbal communication skills that support clear, effective collaboration.
• Adaptable, self-motivated, and comfortable working in a fast-paced, growing company.
• Actively seeks out new knowledge and challenges, driven by a passion for self-discovery and growth.

EDUCATION AND EXPERIENCE

• Bachelor’s degree in Regulatory Affairs, Food Science, Food Safety, or a related discipline.
• 5-7 years of experience in a regulatory or quality assurance role within FDA-regulated food or dietary supplement manufacturing.

EXPECTED SCHEDULE

• Full-time Monday through Friday, generally 8:00 a.m. to 4:00 p.m.
• In-office full-time with some travel to production facilities.

PHYSICAL REQUIREMENTS

• Light work requiring little physical effort.
• Works inside air conditioned/heated area.
• Required to sit for over 80% of the time throughout the workday.
• Required to conduct sensory evaluations on product lines, including tasting and smelling.
• Uses a computer and keyboard throughout the workday.
• Seldom exposed to dust, dirt, cold, fumes, noise, dryness, wetness, vibration, and poor ventilation.
• Occasional exposure to heat and odors.

The physical requirements described above are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Conduct, Quality, Integrity and Culture

Conduct: Medtrition will conduct every aspect of our business with honesty, integrity and openness, respecting human rights and the interests of our employees, customers and third parties.

Quality: Medtrition is committed to safety and product quality. We employ extensive safety programs and controls at all levels. Our quality standards and safety procedures are thoroughly evaluated internally and externally. We continuously strive to improve our performance.

Integrity: Medtrition and its employees will not offer, give, seek or receive, either directly or indirectly, improper inducements for business or financial gain. Where information is confidential, that confidentiality must be protected.

Culture: Medtrition respects the cultural values of our employees, contractors and customers. We also promote a balanced work-life environment. We recognize and celebrate our employees for their hard work and the contributions they make to our company

Pay: $75,000.00 - $95,000.00 per year

Benefits:

• Dental insurance
• Health insurance
• Health savings account
• Paid time off
• Retirement plan
• Vision insurance

Education:

• Bachelor's (Required)

Experience:

• regulatory or quality role: 5 years (Required)

Work Location: In person

Salary : $75,000 - $95,000