Food Labeling Compliance Specialist

Core Responsibilities

• Lead the management of technical requests for all health care products manufactured by Lyons.
• Develop regulatory documentation related to ingredients, formulations, and labels and ensure compliance with corporate and FDA regulations.
• Complete technical document requests (specifications, nutritional composition, GMO, gluten, export certs, etc) to meet customer expectations in documentation turnaround time and accuracy.
• Manage the regulatory process for commercialization of health care products for assigned customers (Label setup, internal specification documentation set up, customer product database set up etc).
• Review and approve healthcare/nutrition product claims to ensure compliance with FDA, FTC, and other applicable regulations.
• Substantiate claims with scientific evidence and maintain supporting documentation and advise Marketing, Sales, and R&D on compliant claim language and guardrails.
• Strategically manage large documentation projects and ability to support customer specific software programs.
• Review and create unit labels and case coding in compliance with all FDA regulations and customer specific requests.
• Review and Approve labels in compliance with all FDA regulations and provide guidance on product label and formula compliance in regions Lyons has a business interest.
• Manage the formula entry and formula change process.
• Act as a lead for all regulatory export documentation (Certificates of Free Sale, Health and Quality Certs, Declarations) in Lyons Health Care.
• Monitor regulatory changes and assess potential risks to claims or communications.
• Responsible for reviewing respective required raw material documents for regulatory clarity.
• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents and recommend changes to company procedures in response to changes in regulations or standards.
• Serve as a Lyons Magnus representative / technical liaison with corporate and professional organizations where Lyons Magnus does business.
• Able to act as a backup to the Regulatory Manager as needed.

Knowledge, Skills and Abilities

• Strong interpersonal skills and demonstrated ability to work with cross functional teams, internally and externally
• Individual must have regulatory technical knowledge
• Ability to manage projects with short and long timelines
• Demonstrated problem-solving skills (pays attention to details and effort to understand causes instead of just the effects) and creativity for developing innovative solutions and applications.
• Excellent written and oral communication skills
• Ability to effectively manage multiple projects under short time lines to produce commercially viable solutions
• Proven ability to multi-task in a fast paced environment
• Prepare a variety of comprehensive administrative and technical documents and reports.
• Read and process written information with high degree of accuracy.
• Work effectively in a general business environment, with a focus on high level of quality, ethics and customer service.
• Achieving results through others where no / little formal lines of authority exist

Required Qualifications

• Minimum of B.S. Degree in Food or Nutritional Sciences, Biology, Chemistry or related field. Professional experience will be considered in lieu of a degree
• 2-7 years of relevant work experience within the food-manufacturing environment,
• Experience in Health Care regulatory claims, labeling, customer interface, and technical documentation.
• Must be computer literate and detail oriented.

Preferred Qualifications

• International compliance experience is a plus.