Consultant(s) are needed for both an US and EU audit. Consultants will have experience with IVDR.
eTMF Audit for medical device trials to be performed by risk based approach; Audit be a QA Audit with a sampling based on the audit plan developed by our client. US audit will follow FDA guidelines and EU audit will follow EU guidelines (Germany, Denmark, France, and Spain).
This is a remote audit and will take place sometime after August 1st. You will be able to work with the client to find a date that works for everyone.
If you are interested, please respond by sending your resume and if you are applying for the US or EU audit to Consultingjobs@advarra.com