Head of Regulatory Affairs (MedTech)

The Regulatory Affairs Director leads the global regulatory strategy of the MedTech AI Division of our client, ensuring that all software and hardware products (SaMD, AI-enabled real-time systems, edge–cloud devices, imaging platforms, connectivity and data solutions) comply with U.S., EU, and international regulations.

Reporting to the VP of Clinical Quality and Regulatory Affairs (CQRA), the role oversees all regulatory activities end-to-end: strategy definition, preparation of submissions (FDA 510(k), De Novo, PMA supplements, EU MDR Technical Documentation), interactions with regulatory authorities, post-market surveillance, and lifecycle management of regulated AI products. The role collaborates closely with R&D, Clinical, Quality Assurance, Cybersecurity, and with global commercial and technology partners to accelerate market access and maintain compliance across the product portfolio.

The Director of Regulatory Affairs supervises the regulatory team and ensures robust documentation, compliant processes, and a proactive approach to evolving regulations (FDA MLMD guidance, EU AI Act, MDR, ISO/IEC standards).

Regulatory Strategy & Compliance

• Develop and implement global regulatory strategies for AI-based medical devices and integrated software/hardware systems.
• Define regulatory pathways for new clinical indications, new AI models, software updates, and new hardware platforms.
• Assess regulatory impact of product roadmaps, including continuous learning AI, cloud connectivity, and EMR integration.
• Ensure compliance with FDA, EU MDR, UKCA, and international regulatory frameworks, as well as IMDRF SaMD guidance, IEC 62304, ISO 14971, IEC 60601, and cybersecurity requirements (FDA Cybersecurity Guidance, EU Cyber Resilience Act).

Qualifications

• Degree in a scientific discipline; Master’s in Regulatory Affairs or relevant certifications are a plus.
• 8–10 years of experience in Regulatory Affairs for medical devices, with direct experience in SaMD and regulated software.
• Minimum 3 years in a managerial or leadership position.
• Strong understanding of FDA and EU MDR regulatory pathways for software medical devices and combined software/hardware systems.
• Familiarity with AI/ML regulatory frameworks (FDA MLMD, EU AI Act).
• Experience with lifecycle management in global markets.