FDA Regulatory Consultant for 510(k) Submission

We are a small, early-stage medical device business seeking an experienced FDA regulatory consultant to guide and manage a 510(k) submission from regulatory strategy through FDA clearance. The product is a clinical medical-assistant kiosk designed for use in healthcare settings. The kiosk will integrate multiple vital-sign measurement functions, including non-invasive blood pressure (NIBP), SpO₂/pulse rate, temperature, and weight, along with software that collects, displays, and manages these measurements. The device is not intended to independently diagnose medical conditions or provide treatment decisions. We are looking for someone who can take a hands-on role throughout the 510(k) process, including: * Reviewing the product design and planned functionality from an FDA/regulatory perspective. * Advising us on any design or functionality changes that could make the FDA clearance process simpler or reduce unnecessary regulatory complications before the product is finalized. * Determining the appropriate FDA classification, product codes, predicate device(s), and overall 510(k) strategy. * Creating a clear roadmap of everything that needs to be completed before the 510(k) can be submitted. * Identifying the testing, validation, standards, and supporting evidence that will be required and advising us on how and where to have this work completed. * Providing us with a detailed list of the documents required for the submission and explaining what information FDA expects in each document. * Guiding our team in preparing documents that can reasonably be completed internally, including providing instructions, templates, examples, and feedback where appropriate. * Preparing or directly assisting with regulatory documents and portions of the submission that are too technical, specialized, or difficult for our team to complete independently. * Preparing and thoroughly reviewing the complete 510(k) submission package before submission, ensuring all documents, testing, supporting evidence, and required information are complete and properly organized, and guiding us through the final FDA submission process. * Completing and preparing any required documents that are too complex for our team to prepare independently or that we are not comfortable completing due to our lack of regulatory experience, ensuring they meet FDA requirements and are ready for inclusion in the final 510(k) submission. We are seeking a highly experienced FDA regulatory professional with a strong track record of successfully preparing and supporting 510(k) submissions through clearance. Experience with Class II medical devices, particularly patient-monitoring equipment, vital-sign monitors, NIBP systems, pulse oximeters, clinical kiosks, or multi-parameter monitoring devices, is strongly preferred. Applicants should be able to provide examples of successful 510(k) submissions they have personally worked on, including K-numbers where publicly available, and explain their specific role in the process. Because FDA testing, preparation, and submission represent a significant financial investment for a small business, it is extremely important that the process is handled carefully and efficiently from the beginning. We are looking for someone who can identify potential regulatory issues early, guide us through the process, and ensure the final 510(k) submission is as complete, accurate, and well-prepared as possible before it is submitted to FDA so that it could be done successfully the first time.