with Software and Test Consultants on the system and design issues. Interacts with QA engineers to ensure that software products... with medical device development processes and FDA 510K and PMA regulatory requirement and process is desirable. Good knowledge...
software products. · Collaborate with cross-functional teams and consultants on product development. · Interact with QA... and FDA 510K and PMA regulatory requirement · Good knowledge of and experience in RF and WiFi software design, device driver...
(s) and/or consultants to deliver projects in alignment with timelines and defined objectives. Organize forums and develop processes... (e.g., FDA standards to Class III PMA devices, etc.). Proficient in using information technology, MS Office, PCs...
, and submission of regulatory filings (e.g., Pre-Submissions, 510(k)s, PMAs, PMA Annual Reports, IDEs, and License Applications... that we do not need external support by recruiting agencies and consultants to fill this vacancy. Thank you for respecting this. Videos...
progress. Plans should address relationships with customers, subcontractors, and consultants. A project communication plan... should be included outlining lines of communication for the project team, customers, subcontractors, and consultants. The Senior Project...
, 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...
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...