Clinical Evaluation Writer – Hybrid (9-Month Contract | High Chance of Extension | Occasional Travel to Ireland)
Position Summary
The Clinical Evaluation Writer is responsible for providing clinical and medical writing support for assigned medical device projects to ensure compliance with EU Medical Device Directive (MDD) and Medical Device Regulation (MDR). This role plays a critical part in preparing high-quality clinical documentation for new and existing products and indications.
This is a 9-month contract position with a high likelihood of extension, operating in a hybrid working model with occasional travel to Ireland. The position primarily focuses on the development of Clinical Evaluation Plans (CEPs)and Clinical Evaluation Reports (CERs), as well as supporting regulatory submissions to Notified Bodies and other regulatory authorities. The role may also support clinical investigation planning and post-market clinical follow-up activities to ensure ongoing MDR conformity.
Key Responsibilities
Clinical & Regulatory Writing
* Prepare, write, edit, and review:
* Clinical Evaluation Plans (CEPs)
* Clinical Evaluation Reports (CERs)
* Post-Market Clinical Follow-up Plans (PMCFPs)
* Post-Market Clinical Follow-up Reports (PMCFRs)
* Instructions for Use (IFUs)
* Summary of Safety and Clinical Performance (SSCPs)
* Ensure all documents comply with:
* EU MDR 2017/745
* MEDDEV 2.7.1 Rev. 4
* Relevant MDCG guidance documents
* Applicable ISO standards
Clinical Data & Literature Evaluation
* Design, conduct, and document systematic literature searches in biomedical databases (e.g., PubMed, Cochrane Library)
* Critically appraise, grade, analyze, and summarize clinical data
* Establish clinical evaluation acceptance criteria
* Perform quantitative comparisons of subject device data to relevant state-of-the-art evidence to demonstrate compliance with General Safety and Performance Requirements (GSPRs)
* Prepare clinical figures, tables, reports, and scientific presentations
Risk Management & Clinical Research Support
* Provide clinical input into medical device risk management processes in accordance with ISO 14971
* Support clinical investigations in compliance with ISO GCP for medical devices) by preparing and reviewing:
* Clinical Investigation Plans (CIPs)
* Investigator Brochures (IBs)
* Case Report Forms (CRFs)
Regulatory & Compliance Expertise
* Maintain a strong understanding of current and evolving global medical device regulations
* Interpret regulatory guidance and communicate regulatory impacts internally and with clients
* Support submissions to Notified Bodies and other regulatory agencies
Information & Evidence Management
* Establish and oversee digital clinical evidence libraries
* Ensure clinical documentation and supporting evidence are accurately organized, traceable, and maintained
Client & Project Management
* Support client engagement through:
* Project scoping and proposal writing
* Proposal management and scheduling
* Leading weekly client progress calls
* Collaborate cross-functionally with project teams to ensure timely and high-quality deliverables
Qualifications & Education
* Bachelor's degree (or equivalent) in a medical, life science, or healthcare-related discipline required
* Postgraduate degree preferred
* Minimum of 5 years of professional experience in a life science, healthcare, or medical writing role
* Demonstrated expertise in clinical/scientific writing and medical device documentation
Required Skills & Competencies
* Advanced medical writing skills with strong experience in:
* Systematic literature reviews
* Clinical data appraisal
* Regulatory clinical documentation
* Excellent attention to detail and ability to critically evaluate scientific information
* Fluency in written and spoken English
* Strong verbal and written communication skills
* High proficiency in:
* Microsoft Word, Excel, SharePoint, Teams, and Outlook
* Experience with document control within a Quality Management System (QMS) is strongly preferred
* Excellent interpersonal, organizational, and client service skills
Preferred Knowledge & Experience
* Clinical research methodology, including:
* Clinical investigation design
* Biostatistics
* Information management and data retrieval systems
* Experience using medical literature databases (e.g., PubMed, Cochrane Library)
* Strong knowledge of EU medical device regulatory requirements