Regulatory Affairs Manager

We are seeking an exceptional Regulatory Affairs Manager to lead and manage all regulatory interactions, including FDA documentation, submissions, and communication. This position plays a critical role in ensuring compliance and regulatory readiness for our AI-based neurotechnology products. The ideal candidate brings medical regulatory expertise—someone who understands the nuances of QMS systems, SW/AI-as-a-medical-device, and non-invasive medical device regulation.

In this position you will:

• Manage all regulatory activities, including preparation and submission of FDA documentation and ongoing communication with authorities
• Oversee and maintain Quality Management System (QMS) processes to ensure compliance with applicable standards
• Collaborate closely with the VP of Medicine, product, and clinical teams to support regulatory strategy and product development
• Ensure regulatory documentation, SOPs, and risk management processes are aligned with company goals and compliance standards
• Stay current on evolving regulations relevant to AI, software-based, and non-invasive medical devices
• Support internal and external audits as needed
• Work collaboratively and independently in a fast-paced startup environment

Our ideal candidate will have:

• 5+ years experience in regulatory affairs for SW/AI-as-a-medical-device, and non-invasive medical device regulation
• Strong understanding of QMS / Quality Assurance frameworks and systems
• Native-level English writing and communication skills, with meticulous attention to detail
• Background in law or life sciences
• Love collaborating with others and working in a team, and independently
• Articulate, clear, and strong communication skills, especially with people from diverse disciplines

This is a full-time position, located in Tel-Aviv. If this sounds exciting, get in touch: [email protected]

At HEMISPHERIC, we care about people and do not discriminate based on... anything.