Senior Director, Global RAQA for AI-Driven SaMD

TeraRecon; New York (NY); Vor Ort; USD 220.000 - 320.000; Vollzeit

Zusammenfassung

TeraRecon seeks a Senior Director, Head of Regulatory Affairs and Quality Assurance to lead global RAQA for its AI-powered imaging SaMD portfolio. Shape regulatory strategy, maintain a robust QMS, and ensure worldwide compliance while enabling rapid product innovation across engineering, product, and clinical teams.

The role requires deep experience with FDA/regional submissions, audits, and post-market surveillance, and a track record of aligning regulatory strategy with business goals in a

Qualifikationen

• Bachelor’s degree in engineering, life sciences, or related field; advanced degree preferred.
• 12+ years in regulatory affairs/QA in medical device or SaMD, including 7+ years in leadership.
• Deep knowledge of FDA QMSR, ISO 13485, EU MDR, MDSAP, IEC 62304, ISO 14971, and global regulations.

Aufgaben

• Lead global RAQA organization and build high-performing teams.
• Maintain and continuously improve the QMS to ensure regulatory compliance.
• Develop and execute regulatory strategies for new products, AI-enabled software, and international expansion.
• Oversee regulatory submissions (FDA 510(k)s, CE/Notified Bodies) and audits.
• Interact with FDA, Notified Bodies, and regulatory agencies during inspections.
• Collaborate with product, engineering, clinical, security, and commercial teams to accelerate compliant product development.

Kenntnisse

Regulatory affairs

Quality assurance

Leadership

Cross-functional

FDA inspections

Ausbildung

Regulatory affairs degree

Jobbeschreibung

TeraRecon seeks a Senior Director, Head of Regulatory Affairs and Quality Assurance to lead global RAQA for its AI-powered imaging SaMD portfolio. Shape regulatory strategy, maintain a robust QMS, and ensure worldwide compliance while enabling rapid product innovation across engineering, product, and clinical teams.

The role requires deep experience with FDA/regional submissions, audits, and post-market surveillance, and a track record of aligning regulatory strategy with business goals in a