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Head of Regulatory Affairs


Bristol, UK

Maintain our QMS processes, report on QMS performance, promote regulatory requirements and support top management; Liaise with external bodies such as EU Notified Bodies (NB) or UK Approved Bodies (UKAB) as the named individual; Working with the Chief Technology Officer, ensure the accurate and timely creation of technical and information governance documentation required to maintain product market access; Working with the Clinical Safety Officer, ensure risk assessments are performed to required standards; Working with the Product Team, ensure that Neuronostics’ products are developed with a complete understanding of the regulatory landscape in which they will ultimately be deployed; Working with the Head of Clinical Operations to take the lead on data management for the clinical studies, specifically EDC setup and management to be compliant with EU Clinical Trials, FDA and GCP regulations;