MDD Class III Design Dossiers for review by the Notified Body. Providing regulatory support for new product development...
regulatory submission/approval experience to include US FDA, EU MDD/AIMD and/or EU MDR, Japan PMDA, Australia TGA and China CDA...
62304, 21 CFR 820.30 and ISO 14971 Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1 and MDD/EU...
Regulation (QSR 21 CFR 820) and EU Medical Device Directive (EU MDD 93/42 EEC) Understanding of Risk Management in accordance...
and implementation of quality systems in compliance with FDA QSR, ISO 13485, MDD and CMDCAS and other relevant requirements at partner...
Directive (EU MDD 93/42 EEC) Understanding of Risk Management in accordance with ISO 14971 General understanding of Design...
) and/or regulatory compliance guidelines for real-world evidence studies or clinical trials (e.g., ISO, MDD/MDR, CFR) Experience working...
. Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1 and MDD. Understanding of the interdependencies...
Regulation (QSR 21 CFR 820) and EU Medical Device Directive (EU MDD 93/42 EEC) Understanding of Risk Management in accordance...
staff for 510(k) submissions, EU MDR submissions, MDD certificate extensions, Life 2000 EUA transition plan and multiple RH...
required to participate in the Material Development Decision (MDD), the pre-/post-Acquisition Strategy Panel (ASP), source selection activity...
such as RoHS, REACH, WEEE, Proposition 65, EU MDD, and EU-MDR. Lead the research in identification of parts and assemblies...
required to participate in the Material Development Decision (MDD), the pre-/post-Acquisition Strategy Panel (ASP), source selection activity...
working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, and the MDD. Familiar...
requirements. Prepare Technical Files /Design Dossier, Change Notifications, and Submissions (e.g. Documentary Audits under MDD...
device engineering experience In depth familiarity with the FDA, ISO, MDD, EU MDR and the medical device industry quality...
knowledge of U.S. and international regulations and standards relevant to BSC, including 21 CFR 806 & 820, ISO 13485:2016, MDD...
) and Design for Manufacture (DFM) experience. Knowledge of FDA QSR's and ISO 13485 design controls, and MDD/MDR (CE Mark...
device engineering experience In depth familiarity with the FDA, ISO, MDD, EU MDR and the medical device industry quality...
knowledge of U.S. and international regulations and standards relevant to BSC, including 21 CFR 806 & 820, ISO 13485:2016, MDD...