Device Directive (MDD) / Medical Device Regulation (MDR) ISO13485 with experience on medical devices. Personal...
devices (GCP/ IRB/EC / FDA & ISO standards/ EU MDD/MDR, etc.) and applies under direction of clinical management. Actively...
, MDD/MDR, CMDR, MDSAP, and all other applicable regulations. Able to professionally negotiate and lead meetings (eg Pre...
to take your career to the next level? If you have a strong background as a Product Assessor within an EU notified body conducting MDD/MDR.../Technical File Reviewer within another Notified Body for active devices, conducting reviews against MDD and/or MDR...
devices (GCP/ IRB/EC / FDA & ISO standards/ EU MDD/MDR, etc.) and applies under direction of clinical management. Actively...
. Director (MDD) and other relevant Ipsen team members Lead clinical project processes Lead cross-functional clinical study... processes in collaboration with CDPD, MDD, GMA, CRO and Ipsen Affiliates (if needed) to identify and gain approval for high...
with applicable regulatory and statutory requirements, including ISO 13485, 21 CFR 820, MDD 93/42/EEC, Regulation (EU) 2017/745..., and ISO 14971. : Issuing advisory notices as necessary, in accordance with the MDD, MDR, and FDA regulatory requirements (21...
is maintained in accordance with relevant regulatory/statutory requirements (including ISO13485, 21 CFR 820, MDD 93/42/EEC..., Regulation (EU) 2017/745 and ISO14971) - Issues advisory notices as required, in accordance to the MDD, MDR, and FDA regulatory...
for planning and conducting audits of medical devices to EU MDD 93/42/EEC, EU MDR 2017/745, Directive 93/43/EEC equivalent to UK... Technology. Knowledge of: Medical devices (active, non-active or software) and Medical device management systems. EU MDD 93...
and the potential impact on the UKD manufacturing and distributing activities. Examples include EU MDR, MDD, Brexit, GxP...