U.S.-Based FDA Medical Device Regulatory Consultant — Prosthetics & Software Compliance

We are seeking a U.S.-based FDA regulatory expert to support a robotic prosthetics software and firmware project. Our technical team will handle development, while you provide guidance on regulatory compliance, documentation, Design Controls, IEC 62304, ISO 13485, ISO 14971, risk management, verification and validation, and FDA software requirements. You must have direct experience with FDA-regulated medical devices and preferably prosthetics, robotic prosthetics, connected devices, or SaMD. Experience reviewing and remediating software documentation is required. Hours will vary each week. Immediate availability is required. Please include a link to your resume, relevant FDA experience, prosthetics or related device experience, and earliest start date. Our main contractor will reach out to you based on your Resume to inquire about your qualifications, so please be honest about your experience.