Regulatory Affairs Specialist
CurrentEnsured compliance to all relevant regulations and Quality Systems requirements in relation to Medical DevicesSupported company goals and continuous improvement initiatives, prepare and support vigilance on regulatory data related to the company’s range of medical devicesSupported the development, collation and review of data for US FDA regulatory submission (510K) and EU MDR submissionSupported the development, collation and review of data for EU MDR Class III Design Dossiers for submission to Notified Body and STEDs for MDR and maintained currency of CE Technical Files aligned with device and process changes.Supported the EU MDR project teamActively supported projects from new product introduction (NPI) and R&D, and developed regulatory strategiesPrepared and submitted MDD / MDR substantial change applications and worked with the notified body to obtain approval.