with a Master’s Degree. Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD...
Part 820, EU MDD, EU MDR and other relevant regulations and standards. Participate in design reviews, test readiness...
., traceability QSRs, ISO and MDD requirements) Ability to work in a fast-paced environment while managing multiple priorities...
. 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...
. Fulfills selected requirements under the European MDR, MDD, Japan PAL and Canada CMDR, etc. as defined within SOPs...