Capstone Search Advisors specializes in placing top talent in the food & beverage industry.  We are seeking a Regulatory Affairs Specialist for a leading food manufacturer.

The Regulatory Affairs Specialist is responsible for ensuring regulatory compliance of new and existing products and supports the Quality Management System. 

RESPONSIBILITIES

Reviews, maintains, and creates label records for food and dietary supplement products by interpreting and applying applicable FDA regulations and guidance.

Compiles and interprets substantiation documentation for accurate and compliant labeling.

As directed, takes ownership of, and delivers successfully smaller projects and specific regulatory elements within larger projects such as innovation, implementation of new regulations, portfolio assessment and change control.

Supports review of product ideations, raw material assessments, formulation assessment, new claims, labels, advertising materials, third party products and related brand activities.

Performs evaluations to substantiate compliant labeling: formula, percent daily values, nutritional claim support, structure/function claims.

Creates formal assessment documents for customer records.

Develop and maintain accurate and compliant label content for dietary supplements and foods, as applicable.

Create and/or revise Standard Operating Procedures (SOPs) to improve the quality management system.

Participate in process qualifications.  Create supporting documents.

Identify guidance documents, regulations, and international standards to provide interpretive assistance.

Perform CAPA investigations, implement corrective actions, and perform effectiveness checks.

Coordinate and maintain sampling and testing procedures.  Facilitate lot release testing.

Review and maintain statistical sampling plans for quality inspections.

Demonstrates a high level of understanding of applicable regulations and implements process improvements when required to ensure quality systems are maintained at a high level.

Support and improve Quality Systems by providing ongoing education on regulatory compliance.

Performs other duties as assigned.

Requirements:

3+ years of relevant prior business experience preferred. 1+ years of experience in regulatory affairs or quality preferred.

Knowledge of international regulations (e.g. Health Canada, EU) a plus.