+ years of US and International medical device regulatory submission/approval experience, to include FDA, MDD, PMDA, TGA...
requirements such as QSRs, FDA, ISO, MDD and other applicable regulations. Experience and understanding Process Validations (IQ,OQ...
medical device quality system regulations, including 21 CFR Part 820, MDD/MDR, ISO 13485:2016, and MDSAP. Working knowledge...
and ISO 13485, MDD requirements. Audit experience a plus. BS degree. Excellent communication, interpersonal...
Device Regulation (CMDR) and EU Medical Device Directive (EU MDD 93/42 EEC), Quality Business System and Key Corporate...
and 804 (MDR regulations), ISO 13485, ISO 14971, and MDD 93/42/EE. 4. Ability to execute established procedures and protocols... such as FDA QSR, ISO 13485, and the MDD required. Experience in a start-up environment preferred. Experience with catheter-based...
management System, ISO 14971:2019 Risk Management, Directive (ED)93/42/EEC (MDD) European Union Medical Device Directive...
and 211, MDD/MDR, and ANSI/AAMI/ISO sterilization standards). Knowledge / Experience developing ways of accomplishing goals...
resolution skills Specialized Knowledge: o Knowledge of current FDA, ISO, MDD, and other related quality and regulatory system...
language. Solid understanding of Medical Device regulations (21CFR820, European MDD, Canadian Medical Device regulations...