core value dossier. May interface with external partners (e.g., CDx providers, licensing partners) and participate...
regulatory strategy plans, from development and throughout the life-cycle of the dossier/product with the focus on nonclinical...
-effective AWS-based solutions to support global dossier initiatives. Ensure alignment with government objectives, data... cloud standards, reference architectures, and roadmaps that support global dossier initiatives. Architecture Design...
, reports, and regulatory dossier. Prepare high quality and data-focused presentations for internal and external audience...
Publishing Dossier Services Submission Authoring & Filing Quality Review Standards Drug, Biologic (IV, Injectable...
submissions (PMA, 510(k), design dossier). ·Led or directly participated in regulatory agency audits / inspections...
memos, change assessment/notifications, technical dossier and submissions. You have experience interacting with regulators...
and technical file/design dossier audits. Maintain regulatory files and tracking databases as required. Evaluate import/export...
and corrective maintenance performed, recording of all information into Dossier Maintenance Software, prepare and submit budget...
and corrective maintenance performed, recording of all information into Dossier Maintenance Software, prepare and submit budget...