Engineering (MBSE, MDA, MDD, MDE), Systems of Systems, architecture modeling, analysis of complex systems, and decision support...
governmental regulations such as FDA QSR, ISO 13485, the MDD, and knowledge of relevant standards. Ability to detail project plans..., QSRs, ISO, MDD/MDR requirements) and other applicable regulations. Experience working with ERP/MRP/Documentation control...
clinical studies, and quality systems, MDD 93/42/EEC; MDR 2017/745; MEDDEV 2.7/1 Rev. 4; ISO 14971; ISO 14155; ISO 13485...
, ISO 14971, 21 CFR 820, 21 CFR 4, IEC 62304, IEC 60601-1, MDD & EU MDR. Experience in Design-Reliability-Manufacturing...
setting; Knowledge of QSRs & ISO 13485; IVDD/IVDR, MDD/MDR, UK MDR 2002, CMDR, GMP, and 21 CFR. Salary Range: $90k-$120k...
MDD Class III Design Dossiers for review by the Notified Body. Providing regulatory support for new product development...
Directive (EU MDD 93/42 EEC) Understanding of Risk Management in accordance with ISO 14971 General understanding of Design...
Regulation (QSR 21 CFR 820) and EU Medical Device Directive (EU MDD 93/42 EEC) Understanding of Risk Management in accordance...
13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1 and MDD/EU MDR. Ability to author technical reports, business...
Regulation (QSR 21 CFR 820) and EU Medical Device Directive (EU MDD 93/42 EEC) Understanding of Risk Management in accordance...