Head of Regulatory Affairs

The Company is seeking a Head of Regulatory Affairs to develop and execute global regulatory strategies for medical devices, diagnostics, software, and digital health technologies. The role will lead regulatory submissions and approvals, engage with health authorities, and guide teams on evolving requirements for AI/ML, cybersecurity, software lifecycle management, and digital health. The successful candidate will partner across product development, clinical, quality, data science, and engineering functions to integrate regulatory requirements throughout development and commercialization. Responsibilities also include building and mentoring a regulatory team, advising executive leadership, and strengthening regulatory processes as the organization grows. Candidates must hold a bachelor’s degree in a scientific, engineering, or related discipline and have at least 12 years of regulatory affairs experience in medical devices, diagnostics, digital health, or software as a medical device. At least five years of experience leading and developing regulatory teams is required, along with substantial knowledge of FDA pathways and global regulations, including 21 CFR Part 820, ISO 13485, EU MDR, and IVDR. Applicants should have hands-on experience with AI/ML-enabled healthcare technologies, successful product approvals, and direct engagement with regulatory agencies. An advanced degree, RAC certification, and experience with novel regulatory pathways are preferred.