Senior Director, Quality Assurance & Regulatory Affairs

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

Role Summary

TeraRecon is seeking a strategic and innovative Senior Director, Head ofRegulatory Affairs& Quality Assurance (RAQA) to lead our globalRegulatory Affairs and Quality organization supporting our AI-powered medical imaging and Software as a Medical Device (SaMD) portfolio.

Reporting to executive leadership, this role is responsible for driving global regulatory strategy, maintaining an effectiveQuality Management System(QMS), ensuring worldwide compliance, and enabling rapid product innovation. The ideal candidate is an experienced leader who partners across Engineering, Product, Clinical, Security, and Commercial teams to accelerate product development while maintaining the highest standards of quality, compliance, and patient safety.

As an AI-first organization, we expect leaders to leverage AI responsibly to improve productivity, automate routine work, strengthen decision-making, and accelerate regulatory and quality operations.

At TeraRecon, AI is foundational to how we innovate and operate. Leaders are expected to embrace an AI-first mindset by leveraging AI to improve efficiency, enhance quality, automate routine work, accelerate decision-making, and foster continuous innovation while ensuring responsible, ethical, and compliant use of AI technologies.

Responsibilities

• Lead TeraRecon’s globalRegulatory Affairsand Quality Assurance organization, providing strategic direction and developing high-performing teams.
• Own and continuously improve theQuality Management System(QMS), ensuring compliance withFDA QMSR,ISO 13485,EU MDR,MDSAP, and other applicable global regulations.
• Develop and execute global regulatory strategies supporting new product development, AI-enabled software, and international market expansion.
• Oversee regulatory submissions, including FDA 510(k)s, CE Mark documentation, international product registrations, and technical files.
• Serve as the primary company representative during FDA inspections, Notified Body audits, and other regulatory agency interactions.
• Lead Management Reviews, CAPA, internal audits, complaint handling, document control, supplier quality, post-market surveillance, and continuous improvement initiatives.
• Partner with Product Management and Engineering to integrate regulatory and quality requirements throughout the software development lifecycle and accelerate product releases.
• Monitor evolving global regulations related to AI, Software as a Medical Device (SaMD), cybersecurity, and digital health technologies.
• Act as the Person Responsible for Regulatory Compliance (PRRC) or ensure organizational compliance with applicable EU MDR requirements.
• Drive operational excellence through data-driven quality metrics, risk management, and AI-enabled process improvements.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related scientific discipline; advanced degree preferred.
• 12+ years of progressive Regulatory Affairs and/or Quality Assurance experience within the medical device or Software as a Medical Device (SaMD) industry, including 7+ years in leadership roles.
• Deep knowledge of FDA QMSR, ISO 13485, EU MDR, MDSAP, IEC 62304, ISO 14971, and global medical device regulations.
• Demonstrated success leading FDA inspections, Notified Body audits, and global regulatory submissions.
• Experience supporting AI-enabled medical devices, cloud software, cybersecurity, or digital health solutions is strongly preferred.
• Exceptional leadership, communication, and cross-functional collaboration skills with the ability to influence executive stakeholders.
• Travel: Approximately 20-30%, including international travel as needed.