Quality System requirements such as QSRs, FDA, ISO, MDD and other applicable regulations. Experience and understanding...
. Extensive knowledge of various regulations/standards (E.g., 21 CFR 820, ISO13485, ISO14971, MDD/MDR). Preferred Skills...
in medical device or biopharmaceutical environment Must be familiar with FDA’s GMPs (QSR), ISO 13485, MDD 93/42, IVDD 98/79/EC...
in medical device or biopharmaceutical environment Must be familiar with FDA’s GMPs (QSR), ISO 13485, MDD 93/42, IVDD 98/79/EC...
in regulatory compliance guidelines for medical devices (e.g. ISO, MDD/MDR, CFR) Physical Job Requirements The above statements...
such as but not limited to, IEC 62304 and IEC 81001-5-1. EU Medical Device Directive (MDD) compliance. EU Medical Device Regulation (MDR...
13485, MDD/MDR, and MDSAP. Implement and maintain the site’s quality system training program. Manage and oversee the...
knowledge of medical device Quality System Regulations (21CFR820), ISO 13485 and MDD requirements is beneficial. Certified...
of regulations and standards Such as MDD, MDSAP, MDR, NMPA and applicable US Code of Federal Regulations CFR 803, 806 and 820, ISO...
. Fulfills selected requirements under the European MDR, MDD, Japan PAL and Canada CMDR, etc. as defined within SOPs...