• Preparation of regulatory documentation and submissions for product approvals


• Development of regulatory plans/strategies for new products and changes to existing products


• Participation in Design Control, Risk Management activities


• Production and review of design dossiers, technical files and change assessments including custom made devices


• Review and preparation of regulatory paperwork in accordance with International standards and new regulations


• Review of product packaging, labelling, IFUs and marketing literature for compliance with specific country regulations


• Facilitate compliance with Vigilance System


• Provide regulatory input to functional groups as required


• Participate in review of RA procedures


• Review and approval of validation, protocols and reports


• Mentorship of RA Associates


• Facilitate in the compilation, communication and monitoring of FSN and recalls

We are Disability Confident and neurodiverse aware.
If you have a disability, please tell us if there are any reasonable adjustments we can make to assist you in your application or with your recruitment process