with appropriate strategies that supports the OPDC objectives and aligns with the business and OPCJ/OPDC/MDD development programs...: Support and implement appropriate filing strategies working with OPCJ, OPDC, MDD and OAPI departments to support registration...
, EU MDD/MDR and/or Canada including writing, compilation, submission, interaction with health authority(s), and continuing...
, and/or efficiencies. Requires background and familiarity with U.S. FDA QSR, requirements including ISO 9001, MDD 93/42, and ISO 13485...
, and/or efficiencies. Requires background and familiarity with U.S. FDA QSR, requirements including ISO 9001, MDD 93/42, and ISO 13485...
. Knowledge of EU MDD / MDR, MDSAP, CMDR, PMDA/PAL, APAC Country requirements, LATAM. Root cause analysis techniques...
resolution skills Specialized Knowledge: o Knowledge of current FDA, ISO, MDD, and other related quality and regulatory system...
, MDCG guidance documents, EU MDD 90/385/EEC and 93/42/EEC, MEDDEV guidance documents, etc.) Excellent written, verbal...
with internal and external audiences Specialized Knowledge: Knowledge of current FDA, ISO, MDD, and other related quality...
and update quality system procedure to achieve continuous compliance to ISO13485, European MDD/MDR, and MDSAP. Assist in the.... Experience with FDA 21 cfr 820, 21 cfr 11, 21 cfr 806, MDD, MDR, MDSAP, EN ISO 13485, EN ISO 14971, IEC 62366-1, EN ISO 15223...