FDA 510(k) Submission Consultant

Shyld AI is looking for an experienced FDA regulatory consultant to support the preparation of our final FDA 510(k) submission. We have already completed the FDA Q-Submission process and have received feedback from the FDA. We are now looking for a contractor who can help us translate that Q-Sub feedback into a complete, well-structured 510(k) application package. The ideal candidate has hands-on experience preparing and submitting FDA 510(k) applications for medical devices, preferably involving one or more of the following areas: ● AI-enabled or software-driven medical devices ● Infection prevention, disinfection, or UV-C technologies ● Hospital equipment or operating room devices ● Devices involving sensors, automation, or environmental monitoring ● IEC 60601, safety, EMC, usability, software, cybersecurity, or risk-management documentation Scope of Work: The consultant will help Shyld AI with: ● Reviewing FDA Q-Sub feedback and identifying what needs to be addressed in the final 510(k) ● Creating a clear 510(k) submission roadmap and document checklist ● Drafting and organizing the 510(k) submission package ● Supporting predicate device strategy and substantial equivalence discussion ● Reviewing intended use, indications for use, device description, and labeling ● Helping prepare required sections such as performance testing, risk management, software documentation, safety/EMC, cybersecurity, and usability, as applicable ● Identifying any documentation gaps before submission ● Advising on responses and positioning to reduce FDA review risk ● Coordinating with our engineering and clinical teams to gather required technical materials Required Experience: ● Prior experience preparing FDA 510(k) submissions ● Strong understanding of FDA expectations for Class II medical devices ● Experience working from FDA Q-Sub feedback ● Ability to draft regulatory documentation clearly and independently ● Familiarity with substantial equivalence strategy and predicate analysis ● Experience with medical device software, AI/ML, UV-C disinfection, infection prevention, or hospital equipment is strongly preferred ● Knowledge of IEC 60601, ISO 14971, IEC 62304, usability, cybersecurity, and performance testing documentation is a plus Deliverables: ● 510(k) submission outline and gap analysis ● Drafted 510(k) sections based on FDA feedback ● Predicate and substantial equivalence support ● Final application package review ● Guidance on any missing testing, documentation, or evidence needed before submission About Shyld AI: Shyld AI is building Physical AI agents for hospitals. Our platform combines edge AI, sensors, and autonomous UV-C disinfection to improve infection prevention, safety, compliance, and workflow automation in high-stakes healthcare environments. We have deployed hundreds of devices across hospitals and are preparing our FDA 510(k) submission based on feedback received through the FDA Q-Sub process. Engagement Type: This is a contract role. We are open to either a fixed-price project or hourly engagement, depending on the consultant’s experience and proposed scope. To Apply: Please include: 1. Examples of FDA 510(k) submissions you have supported 2. Whether you have experience working from FDA Q-Sub feedback 3. Your experience with software, AI-enabled, UV-C, infection prevention, or hospital-based devices 4. Your recommended process for turning Q-Sub feedback into a final 510(k) submission 5. Estimated timeline and availability 6. Whether you can support drafting, strategy, and final submission review