Clinical SME – Design Controls Remediation

Role Summary We are seeking a Senior Clinical Subject Matter Expert (SME) with 8–10+ years of experience to support Design Controls Remediation initiatives. The ideal candidate will possess an advanced clinical degree and deep expertise in medical device clinical research, with a strong focus on regulatory compliance and clinical evidence generation. Key Responsibilities • Perform gap analyses on clinical study plans, protocols, and datasets against design control and regulatory requirements • Support development of Clinical Evaluation Reports (CERs), risk-benefit assessments, and post-market clinical follow-up (PMCF) strategies • Ensure alignment of clinical data with validation protocols and user needs documentation • Provide clinical justification for design updates during remediation activities • Collaborate cross-functionally with Pre-Clinical SMEs and Systems Engineering teams to build a robust evidence strategy Required Qualifications • Advanced clinical degree (MD, PhD, or equivalent) • 8–10+ years of experience in medical device clinical research • Hands-on experience with clinical trials or clinical evaluations under ISO 14155 and FDA regulations • Strong expertise in clinical risk management and regulatory evidence generation • Prior experience in clinical gap remediation, Design History File (DHF), or pre-market approval (PMA) projects • Solid background in clinical study design and data analysis Ideal Candidate Profile • Experience working on design control remediation programs • Strong understanding of regulatory submissions and compliance frameworks • Ability to work independently in a remote, cross-functional environment Apply Now Apply Now