Junior Regulatory Consultant

Criterion Edge is hiring a Junior Regulatory Consultant to provide hands-on support for established regulatory processes. The role focuses on standards management, documentation updates, submission preparation, compliance records, and regulatory research and coordination.

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

Company

Regulatory writing services for life sciences and medical devices

San Luis Obispo, California, USA

https://criterionedge.com/

11-50 employees

Qualifications

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

Regulatory writing services for life sciences and medical devices.

San Luis Obispo, California, USA

https://criterionedge.com

Leadership Team

Lalitha Jonnavithula

Chairman of the Board

Laurie Wyatt Mitchell

President

Company data provided by

AI Tools

Customize Your Resume

Maximize your interview chances

Build Cover Letter

Make your application stand out

Analyze How Well You Fit

Understand your strength & weakness

Required skills

Regulatory Affairs, Regulated Documentation, Document Control, FDA Regulations, EU MDR/IVDR, ISO Standards, International Regulatory Frameworks, Medical Devices, Pharmaceuticals

Preferred skills

Quality Management

Experience

2-5 years