Junior Regulatory Consultant

Job Summary

Providing hands-on regulatory support, the contracted entry-level Junior Regulatory Consultant will manage document maintenance, standards management, and submission preparation activities in a remote work environment.

Key Responsibilities

• Support ongoing standards management activities, including monitoring and maintaining applicable regulatory and consensus standards
• Perform routine regulatory documentation updates using established templates and procedures
• Assist with preparation and organization of documentation for international regulatory submissions

Required Qualifications

• Approximately 2-5 years of experience in regulatory affairs, quality, medical device, pharmaceutical, or related industries
• Working knowledge of regulated documentation and document-control practices
• Familiarity with FDA, EU MDR/IVDR, ISO standards, and/or international regulatory frameworks
• Strong technical writing and research skills
• Ability to execute defined regulatory activities with limited strategic oversight