FDA Medical Device Expert to Prepare eSTAR for Nebulizer Submission

Project Overview We are looking for an FDA medical device expert to prepare the eSTAR submission package for a nebulizer device. This is a compliance-critical project, and we need someone who can take full ownership of the submission preparation process with minimal oversight. We are not seeking general consulting support. We need a true subject matter expert who has personally prepared FDA submissions and can deliver a submission-ready eSTAR package. What You Will Do 1. Review the device documentation, intended use, and supporting materials. 2. Assess the submission strategy and regulatory pathway. 3. Prepare the FDA eSTAR package. 4. Confirm that the product fits the CCQ Product Code. 5. Complete and organize the 510(k)-related sections as needed. 6. Refine the Indications for Use statement and supporting language. 7. Identify missing testing, data, or documentation before filing. 8. Flag predicate, labeling, and regulatory risk issues early. 9. Deliver a clean, submission-ready package. Who We Need The ideal person will have: - Direct, hands-on experience with FDA medical device submissions. - Proven experience preparing eSTAR and 510(k) submissions. - Familiarity with nebulizers, respiratory devices, or similar products. - Strong understanding of substantial equivalence, predicate analysis, and product code selection. - Working knowledge of FDA expectations for labeling, testing, and supporting documentation. - The ability to work independently and produce high-quality, submission-ready work. Deliverables Please provide: - Completed eSTAR submission package. - Submission readiness review. - Confirmation or analysis of CCQ Product Code fit. - List of missing items, data gaps, or risks. - Recommended next steps before filing.