regulatory requirements, such as but not limited to FDA QSR ISO 13485, MDD etc. Previous experience managing outside contract...
Experience in medical software development (FDA or MDR/MDD/IVDR/IVDD regulated) Familiarity with common developer tool sets...
or MDR/MDD/IVDR/IVDD regulated) Job Posted by ApplicantPro...
submissions. Manages responses as requested by regulatory agencies or agents. Oversees and ensures compliance of MDD technical...
requirements, including but not limited to U.S. FDA, EU MDD/MDR, ISO 13485,Health Canada, MHLW, ANVISA, and TGA. Experience in...
requirements, including but not limited to U.S. FDA, EU MDD/MDR, ISO 13485,Health Canada, MHLW, ANVISA, and TGA. Experience in...
procedures to ensure compliance with US CFR, ISO 13485, MDD/MDR, CMDR, MDSAP and all other applicable regulations and drive...’s and experience with EU MDR/MDD, Health Canada, China, etc. You have a strong background in Design Controls. You have detailed...
, such as FDA 21 CFR 820, ISO 13485; MDD; CMDR; MDD 93/42/EEC and other applicable regulatory requirements. Strict attention...
14155:2020, EU MDR 2017/745, MDCG guidance documents, EU MDD 90/385/EEC and 93/42/EEC, MEDDEV guidance documents...
regulations such as FDA, QSR, ISO, MDD, or IVDD Some knowledge in the areas of design controls, verification and validation...