Head of Regulatory Affairs

The Company is seeking a Head of Regulatory Affairs to develop and execute global regulatory strategies for medical devices, diagnostics, digital health, and software-based healthcare technologies. The role will lead regulatory submissions and product approvals, serve as a key liaison with health authorities, and guide teams on evolving requirements for AI, machine learning, cybersecurity, and software lifecycle management. The successful candidate will integrate regulatory considerations throughout product development and support software updates, clinical validation, and post-market activities. Responsibilities also include building and mentoring a regulatory team, advising executive stakeholders, 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 relevant regulatory affairs experience, including five or more years leading teams. Significant experience with medical device or diagnostic regulatory pathways and hands-on work with AI/ML-enabled devices, digital health, or software as a medical device are required. Applicants should have strong knowledge of applicable U.S., European, and international regulations, a record of successful product approvals, and experience engaging directly with regulatory authorities. An advanced degree, regulatory certification, and experience with novel technologies or pathways are preferred.