Description

You will own software quality governance and regulatory compliance for IDE and PMA submissions across the full SDLC.

This role is on-site.

Responsibilities

• Govern software quality practices and ensure readiness from requirements through verification, validation, and release.
• Review and challenge existing SOPs to identify gaps, inconsistencies, or misalignment with FDA expectations.
• Ensure end-to-end traceability across user needs, requirements, risk controls, and verification activities.
• Govern software design controls and maintain audit-ready Design History File (DHF) deliverables.
• Support IDE clinical study readiness through configuration management and change impact assessments.

Required Skills

• 10+ years of experience in software quality assurance within regulated medical device environments.
• Deep understanding of SDLC, design controls, and traceability requirements.
• Proven experience supporting IDE, PMA, or similar regulatory pathways and clinical evidence requirements.
• Hands-on experience with risk-based software verification and validation aligned with FDA standards.
• Strong familiarity with FDA regulations, including 21 CFR 820, 812, and 814.
• Experience reviewing and improving SOPs or quality processes for regulatory compliance.
• Proficiency with test management, defect tracking, and quality documentation tools.
• Ability to provide subject matter expertise for PMA submissions, audits, and FDA interactions.

Key Skills

Education

Any Graduate