Aidoc is recruiting a Head of Regulatory Research (AI SaMD) in Tel Aviv. Join our team!

Aidoc is a pioneering force in clinical AI. Our clinical AI imaging solutions help physicians quickly identify and diagnose urgent cases and improve patient outcomes. Built on Aidoc’s exclusive aiOS, we analyze and aggregate medical data to enable care teams to operationalize the unexpected and work seamlessly with a continued focus on the patient. Aidoc AI is always on, running in the background to change the foreground.

Our solutions are used in more than 1,000 hospitals, including leading health systems in the US. Funded by some of the industry’s leading VC’s, Aidoc has raised more than $250 million to date, and was chosen as one of TIME’s 50 most genius companies.

The Head of Regulatory Research (AI SaMD) is responsible for defining, leading, and executing Aidoc’s regulatory clinical evidence strategy for AI-enabled medical devices. This role owns the most strategic thinking of how to validate clinical AI, and the end-to-end lifecycle of regulatory studies — from early concept and pre-submission strategy through pilot and pivotal studies, FDA interactions, submission closure, and publication.

This is a senior, hands-on leadership role combining regulatory science, clinical research expertise, and program ownership. The Director serves as the clinical and regulatory study lead, orchestrating cross-functional teams and ensuring studies are scientifically rigorous, operationally sound, and strategically aligned with regulatory and product goals.

• Own and lead the strategy, design, execution, and delivery of all regulatory clinical studies supporting FDA submissions.
• Act as the primary clinical and program owner (PM) for regulatory studies, ensuring timely execution across all phases.
• Define study objectives, endpoints, sample sizes, and evidence strategies in collaboration with biostatistics.
• Develop multiple study design options, including detailed risk/benefit and regulatory tradeoff analyses, to support internal and FDA-facing decision-making.
• Author, review, and oversee clinical study protocols, statistical analysis plans (SAPs), data management plans, and clinical study reports (CSRs).
• Design and execute pilot and pivotal studies, including site and PI recruitment, CRO engagement, IRB approvals, and consent processes.
• Lead real-world evidence and hybrid study designs leveraging large-scale Aidoc deployments.
• Partner closely with Regulatory Affairs, Product, AI, Quality, Biostatistics, and Data teams to align evidence generation with product claims and regulatory strategy.
• Lead strategic FDA pre-submissions, participate in FDA meetings, and draft formal responses to regulatory questions.
• Manage study budgets, timelines, vendors, and resources in collaboration with RA and operations teams.
• Ensure compliance with Good Clinical Practice (GCP), applicable regulatory guidance, data traceability, information security, and audit readiness.
• Establish and maintain regulatory study infrastructure, including SOPs, file management systems, and record-keeping practices.
• Support post-submission activities, including additional analyses, predetermined change control elements, and submission closure.
• Publish regulatory studies as white papers or scientific publications, as appropriate.
• Serve as a thought leader in regulatory science for AI-enabled medical devices and help build scalable internal standards and playbooks.

• Advanced degree (Master’s or PhD) in SW-related subjects. Biostatistics, Epidemiology, Clinical Sciences, or a related field.
• 5+ years of experience designing and leading clinical studies for medical devices, including direct support of FDA submissions.
• Demonstrated experience with AI-enabled, sofåtware-based, or data-driven medical devices.
• Deep expertise in clinical study design, regulatory evidence generation, and statistical analysis planning.
• Proven track record of authoring and owning protocols, SAPs, CSRs, and regulatory study documentation.
• FDA-facing experience, including pre-submissions and responses to regulatory questions.
• Ability to lead in a matrixed environment and integrate perspectives across clinical, statistical, regulatory, and product teams.
• Strong operational mindset, with experience managing studies end-to-end, including vendors, budgets, and timelines.
• Excellent written and verbal communication skills, with the ability to clearly articulate complex clinical and regulatory concepts.
• Leadership mindset with the ability to build processes, influence stakeholders, and scale regulatory research capabilities

Our Perks:

• Be part of something big - using cutting-edge technologies to transform the Healthcare industry (while saving patients’ lives)
• We work in a hybrid model, with our new offices located at 34 HaMasger Street in Tel Aviv and parking for employees.
• Amazing and healthy breakfasts and lunches prepared daily by our personal chef!
• Stocked up kitchen & meal card
• Wellness: Aidoc employees-only gym, plus Pilates, Yoga, and functional workouts classes.
• Amazing culture - collaborative, transparent & fun!
• Attractive compensation package & benefits