Compliance SME – Medical Device Software (Remote)

Job Description: Compliance SME – Medical Device Software Department: Regulatory & Quality Assurance Role Overview: We are seeking a highly skilled and detail-oriented Compliance Subject Matter Expert (SME) to lead and support regulatory compliance initiatives for medical device software.

Regulatory Strategy & Engagement: • Lead classification and regulatory pathway analysis for SaMD under FDA guidelines, including 510(k) submissions. • Facilitate early engagement with FDA through pre-submission meetings.

• Bachelor's or Master’s degree in Engineering, Life Sciences, or related field. • 7+ years of experience in regulatory compliance for medical devices or SaMD. • Proven expertise in FDA regulations, ISO 13485, IEC 62304, and ISO 14971.