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
JOB SUMMARY
Location
London,United Kingdom
Job Type
Contract
Salary
£600.00 - £600.00
Posted
2021-04-08
Educational Level
Notavailable
Career Level
Notavailable
Company Name
Address
London,United Kingdom
SimX