Regulatory Compliance Manager

National Beverage•Hayward, CA

43d

About The Position

The Regulatory Compliance Manager ensures that the Company's products meet all regulatory requirements. This includes maintaining and enhancing the systems currently established for compliance with the U.S. Food and Drug Administration (FDA) standards; reviewing and submitting documentation; and testing packaging materials, ingredients and finished products for compliance.

Requirements

Bachelor's degree in food science, microbiology, or other closely related field, or an equivalent combination of education and experience.
10+ years' experience in food or beverage operations and/or quality assurance management.
Recent experience in regulatory compliance management is required.
Computer skills and knowledge of state-of-the-art lab equipment.
Must be able and willing to travel up to 50% of the year.

Nice To Haves

HACCP, ISO, SQF or other food safety certification is desired.
Food safety audit experience desired.

Responsibilities

Manage company portfolio and ensure regulatory compliance of product formulations.
Review of labels and nutrition facts, literature, website content and advertising material to ensure conformance with all pertinent Federal, State and local laws and regulations as well as relevant certification requirements, including Kosher, non GMO, and Organic.
Prepare routine registration dossiers and assist in preparing moderately complex submissions to gain regional registrations.
Assist R&D in defining the correct labeling and nutrition facts.
Generate regulatory information on package labels using the database with ingredient specifications and formula composition.
Prepare and review nutrition facts panel, ingredient statement, allergen identification, product, nutrient content, ingredient and health claims in accordance with all labeling laws and regulations.
Provide review to the Kosher Certification Process to ensure accuracy in usage and compliance of kosher symbols.
Provide review to the Organic Certification Process to ensure accuracy in organic labeling and proper use of certification.
Review labels for consumer safety issues (storage, preparation, use).
Comply with Fair Packaging and Labeling Act by verifying net contents statement and requirements.
Review and approve artwork to ensure required technical label elements are included with proper placement and type size.
Manage formula changes, audit reviews and other information.
Create and maintain product labels and product specification sheets.
Determine regulatory requirements and interpret relevant government regulations for products and raw material ingredients.
Manage international documentation, Certificate of Free Sale and health guarantees, GMO, and Prop.65 compliance documentation.
Assume regulatory compliance for products and documentation.
Review and sign-off for Marketing / Sales literature for products.
Submit report on activities and updates on regulatory items on a monthly basis.
Circulate all documentation with customer service, purchasing, sales, production and product development.
Focus and prioritize regulatory projects and assume responsibility for success.
Assist in management of product recalls for products.
Stay current on regulatory development and trends in the industry that affect the Company's product line.
Serve as a regulatory representative on government agency inspections (FDA, EPA, DOT, OSHA, FAA, etc.) as needed.
Interact with Regulatory Affairs officials both internally and externally to ensure the timely exchange of information.
Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.
Review and respond to Sales and retail customer requests for quality compliance, quality auditing, and food safety management.
Work with Packaging and Quality Assurance teams, as well as suppliers, to verify package/product interaction and shelf stability. Maintain documentation relating to bottle and can warranties.