Regulatory Affairs Manager - Global UDI and EU EUDAMED

  • New Jersey
  • Nr Consulting

Oversee and assist in the collection of UDI related master data for submission to UDI databases. Complete UDI database submissions (e.g. US GUDID) Support and advise on regulatory requirements for UDI direct part marking compliance Assign and maintain the EU Basic UDI for Client portfolio Provide the regulatory UDI requirements for applicable countries. Conduct and document UDI regulatory assessment (including impact of the change on UDI databases and labeling) of product changes. Ensure EUDAMED timelines and required actions for overall implementation are met and communicated clearly to all stakeholders. Be responsible for and complete EUDAMED Actor registration