Director Of Regulatory Affairs

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 Regulatory Strategy: • 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 *****, ISO *****, IEC *****, 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 *****, 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. REQUIREMENTS Education: • Degree in a scientific discipline; Master's in Regulatory Affairs or relevant certifications are a plus. Experience: • 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. Technical Knowledge: • 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. • Fluent spoken and written English. CORE COMPETENCIES • Leadership: ability to guide and motivate teams in a complex technology environment. • Problem-solving: strong capability to address regulatory and technical challenges. • Time management: able to manage multiple submissions and deadlines simultaneously. • Cross-functional collaboration: strong partnership with Clinical, QA, R&D, Business Development, and external partners. • Communication: excellent ability to communicate with internal teams, authorities, and external stakeholders. Equal Opportunity Statement: We support equal opportunities, without any discrimination; The research complies with Legislative Decree ********