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:
โฆ In vitro diagnostics regulations in precision medicine
โฆ Worked on drug trials that use biomarker to select patients into trials
โฆ Understand clinical trial assay (CTA) requirements with diagnostic partners alongside CDx development requirements.
โฆ Built Diagnostic device regulatory strategy plan for biomarker-driven trials.
โฆ Kept up to date on Digital Health technology regulatory requirements and worked on digital pathology/digital health product in a drug trial
Contract Requirements:
โฆ 6 month contract
โฆ Up to 40 hours per week
โฆ Based in the EU or the UK (fully remote)
โฆ Inside IR35 (if based in the UK)