We are currently partnered with a global AI solutions based company that is seeking to bring on a regulatory/medical affairs consultant's onto their current projects. Details of the role is as follows:
Must have experience:
♦ In vitro diagnostics regulations in precision medicine
♦ Worked on drug trials that use biomarker to select patients into trials
♦ Understand clinical trial assay (CTA) requirements with diagnostic partners alongside CDx development requirements.
♦ Built Diagnostic device regulatory strategy plan for biomarker-driven trials.
♦ Kept up to date on Digital Health technology regulatory requirements and worked on digital pathology/digital health product in a drug trial
Contract Requirements:
♦ 6 month contract
♦ Up to 40 hours per week
♦ Based in the EU or the UK (fully remote)
♦ Inside IR35 (if based in the UK)
