regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants... for Next Generation Sequencing and/or PCR assays Facilitate FDA pre-submission meetings Prepare U.S. regulatory submissions (PMA, PMA...
, with support from regulatory consultants as needed. Maintain regulatory documentation, including Technical Files and 510(k)/PMA... 510(k) submissions, including collaboration with regulatory consultants. Strong knowledge of 21 CFR Part 820, ISO...
Consultants on the system and design issues. Interacts with QA engineers to ensure that software products are robust and of very... processes and FDA 510K and PMA regulatory requirement and process is desirable. Good knowledge of and experience in RF and WiFi...
landscapes, providing proactive recommendations to management. Develop and maintain relationships with regulatory consultants... experience with FDA submissions (510(k), IDE, or PMA) and direct interaction with FDA reviewers. Solid understanding of U.S. FDA...
, 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...