QA/RA Project Manager - Remote

Overview

This position is ideal for a detail-oriented and strategic professional who thrives at the intersection of quality assurance, regulatory compliance, and project management. The QA/RA Project Manager will oversee quality and regulatory activities across the product development lifecycle, ensuring medical device software and digital health solutions meet the highest standards of safety, performance, and compliance.

In Short

• Lead quality assurance and regulatory integration across design controls.
• Partner with Regulatory Affairs for audits and regulatory submissions.
• Manage defect analysis and CAPA implementation.
• Champion continuous improvement initiatives using Lean Six Sigma.
• Identify and mitigate risks related to product quality.
• Serve as the QARA lead for product development initiatives.
• Facilitate cross-functional coordination between teams.
• Provide timely reporting on quality status and risks.

Requirements

• Experience in quality assurance and regulatory affairs.
• Strong project management skills.
• Knowledge of FDA 510(k) and CE Mark processes.
• Proficient in Lean Six Sigma methodologies.
• Ability to work cross-functionally.
• Excellent communication skills.

Benefits

• Impactful role in product quality and regulatory readiness.
• Collaborative work environment.
• Opportunities for continuous improvement initiatives.