and experience with MDD and MDR Technical writing experience. Has experience evaluating manufacturing changes for impact on global...
devices (GCP/ IRB/EC / FDA & ISO standards/ EU MDD/MDR, etc.) and applies under direction of clinical management. Actively...
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...
Reviewer within another Notified Body for Orthopaedic and Dental 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...
Medical Device Regulations (MDD, MDR, IVDD, IVDR) Strong organization, communication, and problem-solving skills...
commercialization. This position leads the Business & Product Quality to achieve compliance to the MDD/MDR, MHRA, ISO13485, Quality... and maintains system for and audit compliance with MDD/MDR, MHRA, ISO 13485 and current Quality System Regulation requirements...
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...