2 ISO 13485 Jobs in Scotland

Qualifications: Experience the life sciences or similarly regulated industry (In-vitro Diagnostics preferred) A practical understanding of record audit and material approval processes per ISO 13485:2106 for the Design and Manufacture of In-vitro Diagnostics Experience with an Enterprise Resource Planning System (ERP) Experience with Electronic Document more »

accountable for maintaining compliance of the Quality Management System, input into the management of complaints and post-market activities ensuring that the requirements of ISO 13485:2016, CFR 21 Part 820 IVDD/IVDR are adhered to. The successful candidate shall be responsible for carrying out day-to … timely completion of post market and vigilance related activities Support and input to internal/external audits Essential Knowledge and experience of working to ISO13485, FDA 21 CFR Part 820 Experience of working on post launch IVD or medical device activities in a quality role To find out more about more »