(G059) | CLINICAL EVALUATION REPORT MEDICAL WRITER. 1099

**clinical evaluation report medical writer** **job type**:part-time, contractor, fully remote position **experience level**: experienced criterion edge (ce) is seeking a remote contractor for the clinical evaluation report (cer) regulatory writer role. the position is responsible for providing regulatory writing expertise for the development of initial and annual update cers that support the overall global regulatory submission requirements for the client’s portfolio of medical device products. **please note that previous cer writing experience is required for this role.** **specific responsibilities include**: - prepare regulatory documents and responses to regulatory authorities, specifically working on clinical evaluation reports (cers) and associated documents (cep, sscp, pmcfp, etc). - combine understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge, to support regulatory affairs submissions for ce marking of new devices and maintaining of ce mark for existing devices in accordance with meddev 2.7/1 rev 4, mdd, aimdd, and eu mdr 2017/745. - collaborate with the client and criterion edge librarian to build relevant literature searches for assigned projects (identify relevant key words, design search and selection strategies, etc), perform literature screening against inclusion/exclusion criteria, extract data from included studies, interpret study results, synthesize literature, and prepare summaries into formal reports) for specific medical devices and associated therapeutic fields. - perform c...