Regulatory Affairs Director (Medical Devices)

The Director of Regulatory Affairs leads the global regulatory strategy of the MedTech AI Division, 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).

Key Responsibilities

• 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.

Regulatory Compliance

• 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).
• Monitor regulatory changes worldwide and translate them into internal processes and product implications.
• Support the maintenance of the corporate QMS (ISO 13485, MDSAP) in collaboration with Quality Assurance.

Regulatory Submissions

• Oversee the preparation, review, and submission of all regulatory filings, including FDA 510(k), De Novo, EU MDR submissions.
• Lead interactions with regulatory authorities, including pre‑submission meetings, Q‑Subs, and responses to requests for information.

Post‑Market Management

• Lead post‑market surveillance for SaMD and hardware (PMS, PMCF, safety updates, trending).
• Define regulatory strategies for software and hardware changes, including minor and major updates throughout the lifecycle.
• Oversee labeling, IFU, and technical documentation in collaboration with Clinical, Marketing, and commercial partners.

Authority & Partner Interaction

• Serve as the primary liaison with FDA, Notified Bodies, and other international regulatory authorities.
• Support licensing, co‑development, and market access partnerships by providing regulatory strategy and documentation.
• Participate in technical discussions and regulatory negotiations to secure timely approvals.

Department Leadership

• Manage and mentor the regulatory team.
• Promote a high‑quality documentation culture and strong process discipline.
• Provide internal regulatory training and ensure alignment of regulatory strategy with divisional objectives.