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Job Location | Hull |
Education | Not Mentioned |
Salary | Salary negotiable |
Industry | Not Mentioned |
Functional Area | Not Mentioned |
Job Type | Contract, full-time |
This role will ensure generation of documents in line with EU MDR project schedule. Role includes creating compliance documents such as Clinical Evaluation Reports, Clinical Evaluation Plans, Summary of Safety & Clinical Performance and other relevant clinical documentation to be submitted to notified bodies. Appropriate compliance is mandatory to retain products marketed within Europe.Role Overview:The purpose of this role is to use medical writing and literature review experience to generate Clinical Evaluation Reports (CERs) and other associated clinical documents such as the Summary of Safety and Clinical Performance (SSCP) and Clinical Evaluation Plan (CEP), in accordance with the appropriate regulatory standards to ensure continued CE registration of our products.Responsibilities:Leads completion of clinical evaluation reports (CERs), SSCPs, and CEPs for CE registration; including guidance to less experienced team members 60%Works with internal teams to gain cross-functional inputs and approvals into evidence evaluation documentation activities 15%Generates and maintain reference databases 10%Supports the periodic and ad hoc assessments of device safety and efficacy in support of post-market surveillance and risk management objectives. 10%Support the registration of products in non-EU countries 5%Education: Bachelors in a relevant discipline required. Masters degree or PhD preferred.Experience: