CyberscopeTV

About the job

We are looking for a Quality & Compliance Specialist with excellent experience of Invitro Diagnostics to be an IVD and MDD Regulatory Clinical Performance and evidence Specialist/Usability lead. You will have ten years + Medical Device/ IVD experience Essential experience: * IVDD or MDD * ISO 14971:2012 * EN 13612:2002 - Performance evaluation of in vitro diagnostic medical devices * ISO 62366: Medical devices - Application of usability engineering to medical devices * ISO 13485:2016 Quality Management system experience * MEDDEV 2.7/1 revision 4 Clinical Evaluation You will: * Develop the required clinical performance or clinical evaluation reports for the various product lines including the clinical strategy according to the require standards. * Determine the usability of products based on the usability standards (ISO 62304) and MHRA guidelines * Develop and or obtain stability study reports If you meet the experience required above please apply/call/mail me ASAP for the full spec/more information

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London,United Kingdom