Regulatory Affairs Specialist

Assists in implementing comprehensive regulatory strategies by collaborating with regulatory and cross-functional subject matter experts (SMEs) to ensure alignment with company objectives and compliance with relevant regulations for limited scope typically smaller and less complex projects.

Works under general supervision within established processes and operational policies, exercising independent judgment to ensure adherence to guidelines while achieving objectives effectively.

Demonstrates basic understanding of regulatory's role in the Quality System with basic awareness of product lines, disease states, and customers, possessing general knowledge of business developed through education or past experience.

Applies analytical ...