Hemispheric

Hemispheric builds AI systems that interpret brain activity to enable research and practical neurotechnology applications. The company develops foundational AI models and algorithms for decoding…

hemispheric.ai

Hemispheric

Hemispheric builds AI systems that interpret brain activity to enable research and practical neurotechnology applications. The company develops foundational AI models and algorithms for decoding…

hemispheric.ai

HQRemote

Team Size48

Open Jobs4

Total Funding$1M

Latest Fundraise8 months ago

Join the Team

Regulatory Affairs Manager

On-SiteTel Aviv District

On-Site • Tel Aviv District

We are seeking an 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.

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Part-time • Novi Sad, RS

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

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