knowledge of applicable regulations, such as FDA QSR, ISO, MDD, &/or IVDD. Detailed knowledge of FDA, GMP, ISO 13485, and ISO...
management. Experience with Epic, psychiatry/mental health diagnoses such as MDD, procedures involving TMS/Spravato...
systems designed to meet governmental regulations such as FDA, GMPs, QSR, ISO 13485/9001, and the MDD. Experience leading...
Practice (GCP) and/or regulatory compliance guidelines for clinical trials and medical devices (e.g., ISO, MDD/MDR, CFR...
of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93...
of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93...
, GMP, MDD, EU-MDR, ISO 13485, and ISO 14971. Engineering and technical experience and demonstrated use of quality tools...
regulatory experience preferred Experience with US FDA regulations (Title 21CFR820), EU MDD (93/42/EEC) and EU MDR (2017/745...
Bodies Working knowledge of 510(k), MDD 93/42/EEC Regulatory Affairs Certified RAC (RAPS) Proficient in using Microsoft...
organization. In this role, you will lead the technical execution of Abbott’s Medical Devices Digital (MDD) AI initiatives...