Junior Regulatory Documentation Specialist

Criterion Edge Professional Services Inc.; United States; Remote; USD 52,000 - 76,000; Full time

Job summary

Criterion Edge Professional Services Inc. is seeking a Junior Regulatory Consultant to provide hands-on regulatory support, document maintenance, and submissions preparation.

You will work under senior direction to maintain records, update technical documentation, and coordinate with internal stakeholders to ensure compliant documentation. The role emphasizes efficient execution, standards monitoring, and clear technical writing across FDA, EU MDR/IVDR, and ISO frameworks, with opportunities to

Qualifications

• 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.

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.

Skills

Regulatory writing

Documentation management

Research skills

Attention to detail

Cross-functional collaboration

Job description

Criterion Edge Professional Services Inc. is seeking a Junior Regulatory Consultant to provide hands-on regulatory support, document maintenance, and submissions preparation.

You will work under senior direction to maintain records, update technical documentation, and coordinate with internal stakeholders to ensure compliant documentation. The role emphasizes efficient execution, standards monitoring, and clear technical writing across FDA, EU MDR/IVDR, and ISO frameworks, with opportunities to