Technical Operations Specialist III (Onsite)
to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD...
to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD...
with FDA regulations, ISO13485, MDSAP, MDD/MDR and other applicable global regulatory requirements for manufacturers...
and 211, MDD/MDR, and ANSI/AAMI/ISO sterilization standards). Knowledge / Experience developing ways of accomplishing goals...
including ISO 13485, MDD, and FDA. Develops methods, standards, procedures, plans, processes, programs, and schedules to meet...
Practices), FDA, ISO 13485 and compliance regulations Knowledge on Medical Device Regulatory Standards, MDD and MDR Knowledge...
, ISO 14971, EU MDD, and EU MDR. Knowledgeable on specific requirements for Design Controls and Risk Management is preferred...
such as GMPs, ISO 13485/9001, and the MDD. Familiar with Design Control procedures and requirements. Excellent written and verbal...
9001, and the MDD. Familiar with Design Control procedures and requirements. Demonstrated excellent written and verbal...
knowledge of applicable regulations, such as FDA QSR, ISO, MDD, &/or IVDD. Detailed knowledge of FDA, GMP, ISO 13485, and ISO...
in a medical device discipline GMPs, CFRs, USP, ISO 13485, CMDR, MDD 93/42/EEC, IVD D 98/79/EC, ISO harmonized standards (EN14971...