Matter Expert (SME) on design control and risk management processes, including FDA 21 CFR 820.30, FDA guidance, European MDD... (electrical, mechanical, optical, software) Design control for medical devices development (21 CFR 820.30, ISO 13485, MDD/MDR...
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...