Job Description :
Review and understand gap assessments on Technical Files and Design Dossiers against MDR requirements. Review all technical documentation, including, but not limited to, design verification & validation protocols & reports, risk management files, usability protocols & reports, manufacturing process information, biocompatibility evaluation reports, list of applicable standards, list of general safety and performance requirements, declaration of conformity, and clinical data. Support the collection and provision of data required to submit to EUDAMED. Participate in regulatory impact assessments as it relates to the MDR and relay the information to product specific RA team member and/or design teams. Identify use of appropriate International standards. Bring MDR Regulatory Affairs questions/issues to the attention of MDR Project Management team and Business Units leads. Determine issues which may create regulatory obstacles; investigate and propose solutions