Regulatory Affairs Specialist - Alliance Industrial

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.