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...
. 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...