of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.) You will have good...
13485, ISO 14971, 21 CFR 4, 21 CFR 820, EU Regulation 93/42/EEC (MDD) & 2017/745 (MDR) Able to travel up to 10% of the time...
Practices), FDA, ISO 13485 and compliance regulations Knowledge on Medical Device Regulatory Standards, MDD and MDR Knowledge...
knowledge of applicable regulations, such as FDA QSR, ISO, MDD, &/or IVDD. Detailed knowledge of FDA, GMP, ISO 13485, and ISO...
Standards, MDD and MDR. Knowledge of statistical analysis and design of experiments (DOE) preferred. Knowledge of Computer...
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...
, GMP, MDD, EU-MDR, ISO 13485, and ISO 14971. Engineering and technical experience and demonstrated use of quality tools...