But here at this company, there is nobody representing RA or QA on the management team. In this case, can the non-management RA/QA employee be the management representative? In my past workplaces, the management representative is usually the Director of RA/QA or the Quality Director/Manager. By ISO 13485, the management representative is somebody representing senior management but none of the roles in senior management are in a position to be the 'management representative' as defined in ISO 13485. The only person who knows this piece is a employee outside of management, who manages RA/QA but is not sitting on the management team. The company has a senior management team consisting of people who do have experience in regulatory/quality or RA/QA. My company is in a somewhat unique situation.
