QA Commercial Manager
or biopharmaceutical environment Must be familiar with FDA’s GMPs (QSR), ISO 13485, MDD 93/42, IVDD 98/79/EC, Health Canada and MDR...
or biopharmaceutical environment Must be familiar with FDA’s GMPs (QSR), ISO 13485, MDD 93/42, IVDD 98/79/EC, Health Canada and MDR...
: 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...
, 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...
13485, QSR, MDD 93/42/EEC, IVDD 98/79/EC, TGA, and Canadian Device Regulations. Requirements: High school diploma...
or III device requirements, and FDA/cGMP and MDD regulations. Proficiency with ISO13485 regulations and Design Control...
, ISO13485, 21 CFR 210 and 211, MDD/MDR, and ANSI/AAMI/ISO sterilization standards). Knowledge / Skills / Abilities Experience...
(MDD) and Medical Device Regulations (MDR) Experience in Class III long-term implantable cardiovascular...