Regulatory Affairs Specialist

Job Summary

A company is looking for a Regulatory Affairs Process Specialist for a 6-month contract opportunity.

Key Responsibilities

• Maintain accurate regulatory product blocks and releases using SAP software
• Review change workflows and perform regulatory assessments in the Agile PLM system
• Support IVDR launch activities and manage regulatory dossier systems

Required Qualifications

• Bachelor's degree in Life Science or related field with 2+ years of relevant experience, or a Master's degree with 1+ year of experience
• Basic understanding of technical/scientific principles related to complex product lines or manufacturing processes
• Prior knowledge of databases like Agile, Salesforce, and SAP ERP is preferred
• Experience with regulatory impact tracking and UDI management