Compile, review and submit pre-meeting packages for authority meetings conduct
rehearsal’s and participate in meetings as appropriate.
• Handle Change Requests (CR), Non-conformities (NC) and CAPA cases within area
of responsibility.
• Review of Device documentation, protocols and reports within area of ...
responsibility. Assess the appropriateness of scientific/technical documentation for
specific regulatory purposes.
• Responsible for archiving and retrieving documentation in current archiving
system- (Vault RIM)
• Active participation in Device core groups (development, production and launch
coordination, product maintenance) and GRTs (Global Regulatory Team).
experience
6show more Compile, review and submit pre-meeting packages for authority meetings conduct
rehearsal’s and participate in meetings as appropriate.
• Handle Change Requests (CR), Non-conformities (NC) and CAPA cases within area
of responsibility.
• Review of Device documentation, protocols and reports within area of
responsibility. Assess the appropriateness of scientific/technical documentation for
specific regulatory purposes.
• Responsible for archiving and retrieving documentation in current archiving
system- (Vault RIM)
• Active participation in Device core groups (development, production and launch
coordination, product maintenance) and GRTs (Global Regulatory Team).
experience
6
