. The successful candidate will be responsible for planning and conducting audits of medical devices to EU MDD 93/42/EEC, EU... or software) and Medical device management systems. EU MDD 93/42/EEC, EU MDR 2017/745, Directive 93/43/EEC equivalent to UK MDR...
Device regulations (EU MDR, MDD, MDCG guidelines), ISO 13485 and ISO 14971. Good attention to detail. Have excellent oral...
with EU MDD, MDR, REACH, WEEE, US FDA and other regulatory requirements in countries where our products are used. Support... role. Previous experience conducting risk assessments. Degree educated in Law, Business or Science. Knowledge of MDD, EU...
and the potential impact on the UKD manufacturing and distributing activities. Examples include EU MDR, MDD, Brexit, GxP...
required for MDD registration. To maintain spare parts and tools store and advise the National Maintenance Manager on stock level...
applicable for the manufacture of medical devices and EU MDD/MDR, USA QSR and MDSAP Extensive experience in quality improvement...
and leachable data, toxicological risk assessments, material literature Working knowledge of the MDR, MDD, FDA regulations...
device or pharma indusrtry with clear knowledge of MDD/MDR Regulatory affairs and/or QA background with good computer...
. Director (MDD) and other relevant Ipsen team members Lead clinical project processes Lead cross-functional clinical study... in collaboration with CDPD, MDD, GMA, CRO and Ipsen Affiliates (if needed) to identify and gain approval for high quality investigators...
processes and compliance requirements. Maintain compliance with EU MDR 2017/745, EU MDD 93/42/EEC, ISO60601-1, and WEE...