We have an exciting opportunity for experienced QA experts with prior track record of working with IVD product to join a busy team and support project related to approval and compliance of IVD products.
• Supporting IVD and MDD Regulatory Clinical Performance and evidence
• review and 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
• Suppliers risk assessment, to analyse compliance and assess risk, complaint investigation, including definition of investigation level, root cause analysis, timeliness and quality of response and trending
• Participate in the review and recall of defective product, as necessary, in order to minimise patient risk
• Facilitate development and completion of risk assessments for field issues/complaints in the field.
• Work cross-functionally to ensure the accurate application, use and updates of risk management files
• Support the process owners in the creation of guidelines and quality documents
• Assist in selection and approval of suppliers/sub-contractor
• Maintaining, updating and communicating key processes, SOPs, policies,
• Monitor internal audit non-conformances, perform trend analyses, and present findings
• Technical file preparation
• Strong experience in IVDD or MDD experience
• 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
The role is 100% home based
Michael Bailey International is acting as an Employment Business in relation to this vacancy.