Senior Quality Design & Development Engineer
or III device requirements, and FDA/cGMP and MDD regulations. Proficiency with ISO13485 regulations and Design Control...
or III device requirements, and FDA/cGMP and MDD regulations. Proficiency with ISO13485 regulations and Design Control...
Must be familiar with FDA’s GMPs (QSR), ISO 13485, MDD 93/42, IVDD 98/79/EC, Health Canada and MDR requirements Excellent computer...
: Ensure all design and development activities adhere to applicable regulatory requirements (e.g., FDA, ISO 13485, MDD/MDR...
, requirements including ISO 9001, MDD 93/42, ISO 13485-2003 and the ability to educate others on related subject matter.S trong...
: Ensure all design and development activities adhere to applicable regulatory requirements (e.g., FDA, ISO 13485, MDD/MDR...
or III device requirements, and FDA/cGMP and MDD regulations. Proficiency with ISO13485 regulations and Design Control...
, requirements including ISO 9001, MDD 93/42, ISO 13485-2003 and the ability to educate others on related subject matter.S trong...
RHQ, Division, Corporate, FDA, ISO, MDD, and individual country regulatory requirements) Subject matter expert to local...
or III device requirements, and FDA/cGMP and MDD regulations. Proficiency with ISO13485 regulations and Design Control...
Practice (cGMP) for Medical Devices (21 CFR 820) Knowledge of Health Canada cGMP Knowledge of European MDD and MDR Soft...