Senior Regulatory Specialist

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