, including but not limited to U.S. FDA, EU MDD/MDR, ISO 13485, Health Canada, MHLW, ANVISA, and TGA. Experience in supporting...
investigation compliance with the Food and Drug Administration (FDA), European Union Medical Device Directive (MDD), European Union...
: Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD...
reports Familiarity and the ability to comply with Regulation (21 CFR 820, EU – MDD & MDR) cGMP (current Good Manufacturing...
and maintain the quality system in line with ISO 13485, Medical Device Directive (MDD), Medical Device Regulation (EU-MDR), MDSAP...
and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.) Proficient in Microsoft Office and Minitab Ability to work...
properties. Knowledge of metrology. Requires background and familiarity with U.S. FDA QSR requirements including ISO 9001 MDD...
properties. Knowledge of metrology. Requires background and familiarity with U.S. FDA QSR requirements including ISO 9001 MDD...
preferred with an in-depth understanding of (GMP/QSR/ISO/MDD/MDR) regulations a plus, with focus on inspection points...
14971, ISO 13485, and MDD 93/42/EEC Communication proficiency;verbal and written. Problem Solving and Critical Thinking...