Quality Management System, ISO 149721:2019, Risk Management, Directive (ED)93/42/EEC (MDD) European Union Medical Device...
, etc. You have strong understanding of Medical Device regulations/standards including ISO 13485/14971, 21CFR (803, 806, 820, etc.), MDD/ EU MDR, cGMP...
such as FDA QSR, ISO 13485, the MDD, and knowledge of relevant standards. Expert knowledge of GMP, GDP procedures...
62304, ISO 14971, IEC 82304-1, MDD, and FDA QSR. Experience developing mechatronic products with IEC 60601...
company’s Design Control requirements and consistent with FDA, ISO, and MDD requirements. Participate on cross-functional...
Regulation Working knowledge of Medical Device regulations, such as FDA 21 CFR 820, ISO 13485;MDD;CMDR;MDD 93/42/EEC...
Systems Regulations, including GMP, ISO, FDA, MDSAP, and MDD/MDR. Working knowledge of statistical methods and related...
Matter Expert (SME) on design control and risk management processes, including FDA 21 CFR 820.30, FDA guidance, European MDD... (electrical, mechanical, optical, software) Design control for medical devices development (21 CFR 820.30, ISO 13485, MDD/MDR...
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...
of quality system regulation, including 21 CFR Part 820, ISO 14971, IEC 62304, QSR, ISO 13485, MDSAP and/or MDD/MDR. Experience...