within the medical device-related industry requirements (FDA, MDD, MDR, ISO Standards, etc). Relational database experience...
International Standard, CMDCAS, FDA, and MDD regulations. We operate the Quality System as an overall management system...
, MDD / IVDD / IVDR / MDR/ ISO14971 Strong background in root cause analysis, Risk Management, FMEA, Health Hazard...
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...
(MDD), Bipolar Disorder, Schizophrenia, Borderline Personality Disorder (BPD), and Substance Use Disorder (SUD). Patients...
, FDA, MDD and regulations applicable to the design and development of medical device/science/technology Optical...
regulations, ISO13485, MDSAP, MDD/MDR, and other applicable global regulatory requirements for manufacturers of a diverse finished...
interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD...
latest ISO-13485, ISO-9001, the MDD, and Canadian Medical Device Regulations (CMDR) Must be proficient in Outlook, Word...
-to-patient ratio of 1:8, our unit treats a variety of diagnoses such as Major Depressive Disorder (MDD), Bipolar Disorder...
-to-patient ratio of 1:8, our unit treats a variety of diagnoses such as Major Depressive Disorder (MDD), Bipolar Disorder...
designed to meet governmental regulations such as FDA QSR, ISO 13485, and the MDD. Familiar with GMP, GDP procedures...
Engineering (MBSE, MDA, MDD, MDE), Systems of Systems, architecture modeling, analysis of complex systems, and decision support...
knowledge of FDA/ISO/MDD Quality systems for medical device companies. Quality experience in component and device manufacturing...
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...
setting; Knowledge of QSRs & ISO 13485; IVDD/IVDR, MDD/MDR, UK MDR 2002, CMDR, GMP, and 21 CFR. Salary Range: $90k-$120k...
, ISO 14971, 21 CFR 820, 21 CFR 4, IEC 62304, IEC 60601-1, MDD & EU MDR. Experience in Design-Reliability-Manufacturing...
clinical studies, and quality systems, MDD 93/42/EEC; MDR 2017/745; MEDDEV 2.7/1 Rev. 4; ISO 14971; ISO 14155; ISO 13485...