Regulatory affairs_Medical devices_Bangalore

Job Description

Role & responsibilities : Compile, review and submit pre-meeting packages for authority meetings conduct rehearsals 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). Preferred candidate profile