Responsibilities

  • Manage the interface between the design team and the Project Team
  • Manage the development and population of the Design History File in support of any new programme
  • Responsible for the compilation of all regulatory files
  • Responsible for management of governance reviews boards in support of the project team
  • Accountable for the execution of patient handling studies, design verification, design validation and QbD protocols for each project
  • Establishment of manufacturing and quality control systems at external suppliers.

Requirements 
  • Experience with global submissions, agency interactions and authoring dossiers
  • Comprehensive understanding of design controls, including 21CFR 820.30, risk management processes (ISO 14971), QMS (ISO 13485), relevant human factors and usability guidance, EU MDR, etc
  • Excellent written and verbal communication skills
  • Excellent negotiation skills
  • Management of external manufacturing supply bases
  • An understanding of the principles of design for manufacture
  • Evidence of problem solving
  • Understanding of plastics injection moulding or other high volume
  • Strong time management/organisational skills
  • Performance driven, driving for results and success with a sense of urgency
  • Evidence of team working skills and flexibility