Regulatory Affairs Manager - EMEA
Device regulations (EU MDR, MDD, MDCG guidelines), ISO 13485 and ISO 14971. Good attention to detail. Have excellent oral...
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...
. · Experienced quality and regulatory professional with working knowledge of ISO9001 and MDD / MDR. · Experience of working...