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
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