Fort Wayne, IN Central - Operations / Full-Time / On-site PMA is seeking a highly seasoned Senior Scheduler... schedule governance activities, ensuring consistent application of PMA standards across all project phases and partners...
or quality assurance Experience with ISO 14971 risk management Design controls / DHF documentation 510(k), De Novo, or PMA... experience is a plus Risk management file, FMEA, or hazard analysis experience Consultants and industry professionals...
, and outside consultants as needed. The delivery of regulatory guidance to project teams and external partners is a key activity... for Next Generation Sequencing and/or PCR assays Facilitate FDA pre-submission meetings Prepare U.S. regulatory submissions (PMA, PMA...
components of regulatory submissions (e.g., IDE, PMA, HDE, etc.), ensuring compliance with ICH-GCP and international regulatory...) and surgeon consultants. Oversee the integrity of clinical data collection, analysis, and external reporting, ensuring alignment...
. Our architects, engineers, interior designers, consultants, sustainability specialists, and technologists are passionate about the... your place with Stantec. Your Opportunity The Project Manager Assistant (PMA) works in conjunction with Project Managers...
with Software and Test Consultants on the system and design issues. Interacts with QA engineers to ensure that software products... device development processes and FDA 510K and PMA regulatory requirement and process is desirable. Good knowledge...
development and registration strategies Ensure high-quality and timely regulatory submissions (IND/CTA/NDA/MAA/IDE/PMA... and regulatory consultants, as required, to ensure compliance of drug development activities with all U.S. and international...
that feel like home. Your Opportunity The Project Manager Assistant (PMA) works in conjunction with Project Managers... responsibility of the PMA is to handle as many non-technical aspects of project management as possible to allow the PM to focus...
that feel like home. Your Opportunity The Project Manager Assistant (PMA) works in conjunction with Project Managers... responsibility of the PMA is to handle as many non-technical aspects of project management as possible to allow the PM to focus...
that feel like home. Your Opportunity The Project Manager Assistant (PMA) works in conjunction with Project Managers... responsibility of the PMA is to handle as many non-technical aspects of project management as possible to allow the PM to focus...