and sustaining engineering projects - Prepare, submit and manage regulatory applications to the US FDA (501 (K), PMA and EU Notified.... With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves...
, 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...
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...
member of our F+O Team. As a Senior F+O PMA Consultant at Velosio, you will be responsible for reviewing client business... performed by Consultants, Associate Consultants, and/or subcontractors Lead 1 to 4-person project teams when necessary...
to be an integral member of our F+O Team. As a Senior F+O PMA Consultant at Velosio, you will be responsible for reviewing client..., Vertex, and ExFlow. Coordinate, direct, and oversee work performed by Consultants, Associate Consultants...
, 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...
consultants as needed. The delivery of regulatory guidance to project teams and external partners is a key activity that assists... for Next Generation Sequencing and/or PCR assays. Facilitate FDA pre-submission meetings. Prepare U.S. regulatory submissions (PMA, PMA...
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...
. Team Leadership: Mentor and coach leads and consultants, providing guidance and oversight throughout the project lifecycle... experience working with Dynamics 365 Finance and Operations, with primary focus on Project Ops, PMA and Finance Minimum 8 years...
and coach leads and consultants, providing guidance and oversight throughout the project lifecycle. Sales & Advisory Support... with Dynamics 365 Finance and Operations, with primary focus on Project Ops, PMA and Finance Minimum 8 years of experience...