Quality 7 Compliance Specialist - Medical - wfh

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.