such as FDA, MDD Notified Body, Health Canada, ISO, Acumed’s EU Authorized Representative Manage field actions including...
this information to stakeholders. EU regulations including, but not limited to, MDD 93/42/EEC, MDR 2017/745, IVDD 98/79/EC, and IVDR...
within the medical device-related industry requirements (FDA, MDD, MDR, ISO Standards, etc). Relational database experience...
, MDD / IVDD / IVDR / MDR/ ISO14971 Strong background in root cause analysis, Risk Management, FMEA, Health Hazard...
International Standard, CMDCAS, FDA, and MDD regulations. We operate the Quality System as an overall management system...
as well as those of our customers and the ISO 13485 International Standard, CMDCAS, FDA, and MDD regulations. We operate the Quality System...
or biopharmaceutical environment. Must be familiar with FDA’s GMPs (QSR), ISO 13485, MDD 93/42, IVDD 98/79/EC, Health Canada and MDR...
develop comprehensive regulatory strategies relating to PMA, IDE, ''510(k) premarket notifications, EU MDD Technical File/MDR...
and External Audits as required. Ensure compliance with ISO 13485, MDD, 21 CFR 820, GMP, and other applicable regulations...
. Knowledge of metrology. Requires background and familiarity with U.S. FDA QSR, requirements including ISO 9001, MDD 93/42, ISO...