Head of Regulatory Affairs

Head of Regulatory Affairs

About the Company

Rapidly growing healthcare technology company developing AI/ML diagnostics and software as a medical device

Industry
Medical Devices

Type
Privately Held

About the Role

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 medical technologies. The role will lead regulatory submissions and approvals, serve as a key liaison with health authorities, and guide products from development through commercialization and post-market activities. The successful candidate will partner across technical, clinical, quality, and commercial functions, build and mentor a regulatory team, and advise senior leadership on regulatory risks and opportunities. Responsibilities also include monitoring evolving requirements and strengthening regulatory processes as the organization grows. Candidates should have a bachelor’s degree in a scientific, engineering, or related discipline, at least 12 years of relevant regulatory experience, and five or more years leading regulatory teams. Required expertise includes medical device or diagnostic regulatory pathways, including 510(k), De Novo, PMA, IDE, or IVD submissions, along with experience supporting AI/ML-enabled or software-based medical technologies. Strong knowledge of FDA regulations, ISO 13485, EU MDR, IVDR, and global requirements is essential, as is a record of successful product approvals and direct agency engagement. An advanced degree, RAC certification, and experience with novel pathways, cybersecurity, AI governance, or real-world evidence are preferred.

Functions

• Product Management
• Engineering