to meet governmental regulations such as FDA QSR, ISO 13485, the MDD, and knowledge of relevant standards. Ability to detail... (e.g. traceability, QSRs, ISO, MDD/MDR requirements) and other applicable regulations. Experience working with ERP/MRP...
with MDD-03128, MDD-01505, MDD-02268, MDD-01737, EBP-03287 Proficiency with Microsoft Office Suite (including but not limited...
including ISO 13485, MDD, and FDA. Develops methods, standards, procedures, plans, processes, programs, and schedules to meet...
Inspector in accordance with MDD-00948/MDD-01464. Qualifications: Required: High school diploma or GED. 1+ years...
of medical device management. Well versed in US FDA and EU MDD/MDR requirements A thorough knowledge of related disciplines...
within a Medical device or other regulated industry with knowledge of Risk Management (ISO 14971 2019), MDD (Medical Device Directive...
. Experience with regulatory submissions and approvals, including 510(k) or PMA. Knowledge of FDA 21CFR Part 820, EU MDD, EU MDR...
with MDD-03128, MDD-01505, MDD-02268, MDD-01737, EBP-03287 Proficiency with Microsoft Office Suite (including but not limited...
a variety of diagnoses such as Major Depressive Disorder (MDD), Bipolar Disorder, Schizophrenia, Borderline Personality Disorder...
with applicable quality system and regulatory requirements (traceability, QSRs, ISO, MDD/MDR as applicable). Perform other duties..., MDD/MDR requirements). Proficiency with Microsoft Office (Excel, Word, PowerPoint, Outlook, Power BI etc.). Lean / Six...