; Experience and knowledge of Canadian Medical Device Regulations, MDD, MDSAP and ISO standards preferred; Minimum of three years...
and update quality system procedure to achieve continuous compliance to ISO13485, European MDD/MDR, and MDSAP. Assist in the.... Experience with FDA 21 cfr 820, 21 cfr 11, 21 cfr 806, MDD, MDR, MDSAP, EN ISO 13485, EN ISO 14971, IEC 62366-1, EN ISO 15223...
, such as FDA 21 CFR 820, ISO 13485; MDD; CMDR; MDD 93/42/EEC and other applicable regulatory requirements. Strict attention...
, MDD, MDR Knowledge of IVDD, IVDR and/or 3P510K is preferrable. Minimum 3 year managing experience in auditing...
Position Overview In compliance with FDA, European MDD/MDR & ISO regulations, the Quality Compliance Specialist...
and MDD/MDR. Proficient with core Quality skills, e.g., internal auditing, statistical analysis techniques, problem-solving...
working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, and the MDD. Familiar...
, MDD, MDR Knowledge of IVDD, IVDR and/or 3P510K is preferrable. Minimum 3 year managing experience in auditing...
, PowerPoint, Visio, etc.), and Statistical Analysis tools (or equivalent). Working knowledge of FDA, ISO, MDD and the medical...
performance of this task is a must. Knowledge of SP/SSP's, MDP's/MDD's, SI's, SDD's, and DI's is a plus. Must be able to qualify...