Contract Clinical Evaluation Writer

I'm hiring! I'm looking for an independent 1099 CER writer to help with the end of the year push and potential to assist with early 2027 projects as well. Must be US-based. Please no consultancies, agencies, or third-party recruiters. Reach out with any questions!

Posted by: Marysa Mezzetti, Consultant/Owner

Company Description

Mezzetti Consulting is a specialized consultancy focused on EU clinical and regulatory strategy for medical devices.

Role Description

We are looking for an experienced Contract Clinical Evaluation Writer to support the development, writing, and updating of Clinical Evaluation Reports (CERs) and related documentation on an ad hoc, as-needed basis. This is a flexible, part-time contract role suited to a freelance medical writer or regulatory consultant who can work independently, meet deadlines, and deliver high-quality, audit-ready documents with minimal oversight. Work will be assigned per project and there is no guarantee of ongoing or recurring hours, and engagements may range from a single report update to full CER creation. We are not looking to engage a consulting or contracting company.

Responsibilities

• Draft, update, and revise Clinical Evaluation Reports (CERs) in accordance with EU MDR (2017/745), MEDDEV 2.7/1 Rev 4 requirements, and client templates
• Conduct and document systematic literature searches and literature appraisals to support clinical evaluation
• Collaborate with client Regulatory Affairs, Quality, and R&D teams to gather source data and clarify technical details
• Incorporate feedback from internal review and Notified Body queries
• Ensure all deliverables are submission-ready and consistent with applicable regulatory guidance
• Other tasks as needed related to execution of clinical evaluation projects.

Required Qualifications

• Bachelor's or advanced degree in life sciences, biomedical engineering, nursing, pharmacy, or related field
• 3+ years of experience independently writing Clinical Evaluation Reports
• Strong working knowledge of EU MDR (2017/745) and MEDDEV 2.7/1 Rev 4
• Experience conducting systematic literature reviews (PubMed, Embase, or similar databases)
• Excellent technical writing skills with strong attention to detail and regulatory precision
• Ability to work independently and manage multiple concurrent projects with minimal supervision
• Comfortable working within tight, deliverable-driven timelines
• Client-facing/consulting experience is preferred

Engagement Details

• Structure: Ad hoc / part-time — work is assigned per project or report cycle, not a fixed weekly schedule
• Estimated volume: Variable, up to 20 hours a week during peak times
• Location: Remote; occasional calls during EST for project kickoffs and reviews
• Duration: Ongoing contractor relationship