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:

• Proven experience in regulatory affairs for SW/AI-as-a-medical-device, and non-invasive medical device regulation
• Strong understanding of QMS / Quality Assurance systems and frameworks.
• Exceptional English writing and communication skills, with meticulous attention to detail.
• Background in law or science – ideal candidates blend analytical thinking with regulatory insight (not purely technical).
• Sharp, articulate, and modern personality with strong interpersonal and communication skills.
• Love collaborating with others and working in a team
• Have superb emotional intelligence and 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.