range of mental health conditions across all age groups, including but not limited to Major Depressive Disorder (MDD), Generalized...
and UDI/MDD/MDR/UKCA Regulatory Compliance project experience is preferred. Demonstrated interpersonal, communication...
applications (Word, Excel, PowerPoint, Project, etc), and experienced work in a Quality Management System and UDI/MDD/MDR/UKCA...
or biopharmaceutical environment. Must be familiar with FDA’s GMPs (QSR), ISO 13485, MDD 93/42, IVDD 98/79/EC, Health Canada and MDR...
authoring EU Clinical Evaluation Plans and Reports (CEP, CER) in compliance with applicable regulations and guidance (MDD, MDR...
such as RoHS, REACH, WEEE, Proposition 65, EU MDD, and EU-MDR. Lead the research in identification of parts and assemblies...
(GMP), MDD, EU MDR, MDSAP, and ISO 13485 standards. As a Regulatory Compliance Specialist, you will play a vital role in... is a plus. Knowledge of FDA QSR, MDD, MDR, ISO 13485, and MDSAP preferred. Strong verbal and written communication skills...