CER Medical Device/
Medical Writer Jobs
CER medical device/medical writer recruitment is one of our core areas of expertise. We are proud to work with the world’s leading medical device and IVD companies in Europe, and with some of the best CER/medical writing professionals. We work with global corporates, startups, Notified Bodies, IVD and medical device manufacturers, and consultancies.
Whether you’re looking for a new challenge in CER/medical writing or you need to find talent for your team, we can help.
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What do CER medical writer jobs involve?
Companies that sell medical devices in Europe must produce a clinical evaluation report (CER), which documents the clinical evaluation results of their devices. This report must comply with MEDDEV 2.7.1 revision 4 and the Medical Devices Regulation (MDR) 2017/745.Â
Working as a clinical evaluation report writer or medical writer in medical devices involves assessing and analysing pre and post market clinical data, and reaching conclusions about the medical device’s compliance with requirements for safety and performance. The completion of a clinical evaluation report is an important step for companies working towards CE marking.
Clinical evaluation report writers can write CERs for all types of medical devices: for example general medical devices, active implantable medical devices, in vitro diagnostic medical devices and software as a medical device (SaMD).
What responsibilities do CER medical device writers have?
CER/medical writing as a job comes with lots of responsibilities, especially when taking on a clinical evaluation report writing job for medical devices. These CER responsibilities include, but aren’t limited to, the following:
Evaluating clinical evidence from sources such as clinical investigations, literature, post-market surveillance, risk, and post market clinical evaluations
Analysing clinical evaluation results in preparation for applications and submissions relating to the product
Planning for and leading on CER related projects and processes
Collaborating with clinical, regulatory and quality team members and departments across the business
Contributing to key clinical evaluation reporting deliverables including clinical evaluation plans and reports (CEP/CER), PMS and PMCF reports, regulatory responses, SSCPs and other related documentation
Ensures attention to detail, consistency and integrity of data across all deliverables
Responsible for compliance with regulations and guidance (ISO13485, ISO14155, ISO14791, MEDDEV 2.7.1, MDR, and EU and FDA guidance documents) and applicable SOPs and DOP
Contributing to regulatory submission and communication documents, risk reviews and regulatory inquiries
Review key documents including but not limited to IFUs, risk management files, clinical evaluation protocols, patient guides and physician training materials
Types of CER medical device/medical writing jobs
Clinical evaluation report writing/medical writing falls under a number of job titles: including:
- Clinical Evaluation Report Specialist
- CER Writer
- Clinical Writer
- Clinical Evaluation Leader
- Clinical Evaluation Manager
- CER Medical Writer
- Clinical Study Report Writer
- Medical Writer
CER medical device jobs near me
Are you looking for a new medical device quality job? Check out our latest vacancies below or head to the Vacancies page to search for your preferred location.
What is the average salary for CER/medical writers?
The salary for writing clinical evaluation reports for medical devices can vary massively across Europe, between countries, seniority and company size. You can speak to our team of CER recruitment specialists about your salary expectations and how they measure up against the market. Request a call back here.
How do I become a medical device CER writer?
Writing a clinical evaluation report requires a mix of scientific, medical/clinical, regulatory, and technical competences.The skills and experience you will need as a medical device CER writer include strong writing experience, clinical knowledge, device knowledge and regulatory knowledge. Â
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