in medical device/pharma industry. Experience to include ISO 13485, 21 CFR 820, MDD 93/42/EEC, EU MDR 2017/745, and MDSAP...
, ALS), Psychiatry (e.g. schizophrenia, bipolar, MDD, sexual dysfunction, sleep disorders), Pain and Rare Diseases (e.g. Duchenne’s, NMO...
, such as but not limited to FDA QSR ISO 13485, MDD etc. Knowledge of DBS Fundamentals, Danaher Material Systems and and Lean DBS tools...
and interpretation of applicable regulations, guidelines and policy statements (QSR, MDD, and ISO) Excellent written and oral...
/ MDD / CE, IEC 62304 / 62366, Design Controls / Design History File, Requirements Definition, Risk Management, Validation...
/ MDD / CE, IEC 62304 / 62366, Design Controls / Design History File, Requirements Definition, Risk Management, Validation...
., traceability QSRs, ISO and MDD requirements) Ability to work in a fast-paced environment while managing multiple priorities...
-on experience with FDA, QSR, ISO, MDD, GDP, GLP, GMP and/or other local or international quality systems requirements. Utilize...
such as QSRs, FDA, ISO, MDD and other applicable regulations. Experience and understanding Process Validations (IQ, OQ, PQ), 6S...
with internal and external audiences Specialized Knowledge: Knowledge of current FDA, ISO, MDD, and other related quality...