Biomedical Engineer Subject Matter Expert

Job Summary

Providing scientific and regulatory support, the full-time Biomedical Engineer Subject Matter Expert will evaluate medical devices, manage regulatory submissions, and coordinate with FDA stakeholders while working remotely.

Key responsibilities

• Perform technical and regulatory reviews of medical devices to assess design, intended use, and performance data
• Evaluate scientific and engineering information submitted for various regulatory pathways, including 510(k) notifications and De Novo requests
• Analyze complex engineering issues to support regulatory recommendations and ensure consistent application of standards across teams

Required qualifications

• Bachelor's degree in Engineering, Biomedical Engineering, or a closely related discipline
• Minimum of seven years of professional experience in engineering, medical devices, or regulatory affairs
• Demonstrated knowledge of medical device technologies and FDA regulatory frameworks
• Strong analytical and technical writing skills for clear communication of complex concepts
• Proficiency in Microsoft Office Suite applications