regulatory requirements including but not limited to Site, Division, Corporate, FDA, ISO, MDD, MDR and individual country...
reports Familiarity and the ability to comply with Regulation (21 CFR 820, EU – MDD & MDR) cGMP (current Good Manufacturing...
Systems Regulation, ISO 14971, MDD 93/42/EEC, EU MDR, and other relevant international laws. Outstanding problem-solving...
14971, ISO 13485, and MDD 93/42/EEC Communication proficiency;verbal and written. Problem Solving and Critical Thinking...
under MDD/ MDR) for both regulatory agencies and distributors. Creates, reviews and approves change requests. Assist...
, ALS), Psychiatry (e.g. schizophrenia, bipolar, MDD, sexual dysfunction, sleep disorders), Pain and Rare Diseases (e.g. Duchenne’s, NMO...
with a Master’s Degree. Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD...
Part 820, EU MDD, EU MDR and other relevant regulations and standards. Participate in design reviews, test readiness...
, ISO 14971, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, MDSAP, IEC 62304, IEC 62366 and IEC 60601. Essential Job Functions... of applicable medical device regulations and standard such as ISO 13485, ISO 14971, IEC 62304, IEC 60601, 21 CFR Part 820, MDD 93/42...
., traceability QSRs, ISO and MDD requirements) Ability to work in a fast-paced environment while managing multiple priorities...