Junior Regulatory Consultant
Free to start · No card · 5 credits the moment you sign up
Job description
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.
- 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
- 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.
Originally posted on Himalayas
Prepare your application
Use the description above to assess your fit for Criterion Edge. This checklist is guidance from Resumize, rather than additional requirements from the employer. Imported listings can be shortened or change after collection, so confirm the complete description and current availability before sending an application.
Match requirements to evidence
Identify the responsibilities and skills the employer explicitly names. For each important requirement, choose one example from your work, education, training, or projects. Explain what you did, how you did it, and what changed as a result. Include a measurable outcome when you can support it. If you lack a requirement, describe related experience accurately instead of adding an unfamiliar skill to your resume.
Put the most relevant examples near the top of your resume. Keep job titles, dates, qualifications, and contact details consistent across your application materials. Use the employer’s terminology when it describes your experience accurately; a copied list of keywords does not explain your contribution. A short, specific bullet is easier to review than a paragraph that mixes several unrelated duties.
Check the working arrangement
Confirm the location, schedule, employment type, and any eligibility requirements on the employer’s site. A remote label does not establish worldwide eligibility or flexible hours. If compensation, benefits, equipment, travel, or contract duration are missing from this listing, write down your questions for the recruiter. Do not assume details from another opening at the same company apply to this role.
Review before submitting
Follow the employer’s requested file format and application instructions. Open your exported resume and check that its text is selectable, its sections read in order, and its links work. Proofread names, dates, and contact information. Share confidential work samples only when you have permission, and use an anonymized example when necessary.
Submit through a trusted employer or recruiting destination. If the original listing has disappeared, search the employer’s careers page for the title rather than assuming the vacancy remains open. Save the application date, job reference, and the version of your resume you sent. Those details help you prepare for a later conversation and avoid submitting conflicting information through several job boards.
Review your resume for writing and readability feedback, or browse other openings if this opportunity is unavailable.