Role Summary

The Junior Regulatory Consultant provides hands-on regulatory support for established processes, document maintenance, standards management, and submission preparation activities. This role is best suited for work where the regulatory strategy or requirements have already been defined and the primary need is efficient execution, coordination, research, and documentation.

Key Responsibilities

• Support ongoing standards management activities, including monitoring, tracking, and maintaining applicable regulatory and consensus standards.
• Review standards and regulatory requirements for updates and identify changes requiring internal assessment.
• Maintain standards inventories, applicability assessments, and related compliance records.
• Perform routine regulatory documentation updates using established templates, procedures, and source records.
• Draft and update technical and regulatory documents based on information supplied by internal subject matter experts.
• Support preparation and organization of documentation for international regulatory submissions.
• Compile submission components, supporting evidence, and required records.
• Assist with maintenance and development of Technical Documentation.
• Support document gap assessments and remediation activities under senior regulatory direction.
• Assist with Quality Management System documentation, including SOPs, work instructions, forms, and controlled records.
• Maintain regulatory trackers, databases, compliance matrices, and submission records.
• Support development and maintenance of compliance information management systems.
• Conduct regulatory and standards research and summarize findings for review.
• Coordinate with internal stakeholders to obtain necessary documentation and records.
• Provide ongoing ad-hoc regulatory and documentation support as business needs arise.

Typical Assignments

• Standards monitoring and standards database maintenance
• Updating documents to current templates
• Drafting documents from provided source records
• Maintaining regulatory trackers Criterion Edge | Regulatory Consulting
• Compiling submission documentation
• Technical Documentation maintenance
• QMS document updates
• Regulatory research
• Compliance database administration
• Supporting straightforward international submissions

Recommended Experience

• Approximately 2-5 years of regulatory affairs, quality, medical device, pharmaceutical, or related industry experience.
• 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, research, organization, and documentation skills.
• Ability to execute defined regulatory activities with limited strategic oversight.