in compliance with regulatory requirements (GMP, ISO, MDD/MDR) & LeMaitre policy & procedure requirements Capture & disseminate...
Regulation Working knowledge of Medical Device regulations, such as FDA 21 CFR 820, ISO 13485;MDD;CMDR;MDD 93/42/EEC...
, and EU-MDR/MDD rules and regulations Position Requirements Excellent verbal and written communications...
in a medical device discipline GMPs, CFRs, USP, ISO 13485, CMDR, MDD 93/42/EEC, IVD D 98/79/EC, ISO harmonized standards (EN14971...
Medical device standards, EU MDD, EU MDR, and 21 CFR 820. Working knowledge of Quality System Regulation and FDA Consensus...
& MDD) and Quality (QSR & ISO 13485) issues or similarly regulated industry Expertise in neutron activation, activity...
with laboratory software is preferred Familiarity with the medical device Regulatory (FDA & MDD) and Quality (QSR & ISO 13485...
resource allocation Familiarity with the medical device Regulatory (FDA & MDD) and Quality (QSR & ISO 13485) issues...
device Regulatory (FDA & MDD) and Quality (QSR & ISO 13485) issues or similarly regulated industry Experience working...
(FDA & MDD) and Quality (QSR & ISO 13485) issues or similarly regulated industry Experience with design verification...