Principal Regulatory Specialist
, EU MDD/MDR and/or Canada including writing, compilation, submission, interaction with health authority(s), and continuing...
, 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...
: Remote About the Company Tracing its roots back to 1933, MDD is one of the world’s top forensic accounting firms... specializing in economic damage quantification. With forensic accounting professionals in over 40 offices on 5 continents, MDD...
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...