MAJOR DUTIES AND RESPONSIBILITIES FDA 510(k) submission o Conduct comprehensive review of technical documentation (design controls, V&V, risk, labeling, clinical evidence, and software as applicable) to ensure completeness, quality, and regulatory compliance o Perform detailed regulatory gap assessments against FDA requirements (21 CFR Parts 807, 820, and applicable FDA guidance documents) o Author, compile and deliver a complete 510k submission, including preparation in FDA eSTAR format, o Lead submission lifecycle activities, including: o Acceptance Review support (RTA readiness) o Substantive Review coordination o Drafting and submission of responses to FDA requests for Additional Information, Interactive review communications o Updating submission content and modules as required o Interface cross-functionally to incorporate Business inputs and ensure alignment throughout the review process. This role is a hand-on, execution-focused contractor position responsible for reviewing technical documentation, ensuring regulatory compliance, authoring submission materials, and supporting documentation regulatory strategies across US, EU and global markets.