Job Description
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
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