Junior Regulatory Consultant
About The Position
The Junior Regulatory Consultant provides hands-on support for established regulatory processes, document maintenance, standards management, and submission preparation. The role focuses on executing and coordinating activities where regulatory strategy or requirements have already been defined, including research, documentation, and record management. The consultant supports standards monitoring and maintenance, routine updates to technical and regulatory documents, preparation of international submission materials, Technical Documentation maintenance, and Quality Management System documentation. The role also includes maintaining trackers, databases, compliance matrices, and submission records; conducting research; coordinating with internal stakeholders; and providing ad-hoc regulatory and documentation support as needed.
Requirements
- 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.
Responsibilities
- Monitor, track, and maintain 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.
- Update regulatory documentation using established templates, procedures, and source records.
- Draft and update technical and regulatory documents using information from 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 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 ad-hoc regulatory and documentation support as business needs arise.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
