Senior Regulatory Specialist

Job Summary

Leading regulatory support for product development teams, the full-time Senior Regulatory Specialist will prepare regulatory documents, coordinate labeling activities, and ensure compliance with global regulations in a remote setting.

Key responsibilities

• Leads regulatory support by preparing regulatory opinion documents and reviewing design control documentation
• Develops and approves labeling, advertising, and promotional materials to ensure regulatory compliance
• Maintains awareness of global regulatory changes and assesses their impact on product development

Required qualifications

• Bachelor's degree in a relevant field
• 6+ years of experience as a regulatory specialist in the medical device or pharmaceutical industry
• Knowledge of FDA, EU, and other regulatory body regulations
• Regulatory Affairs Certification (RAC) preferred
• AATB CTBS certification preferred