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See Open Roles

Meet our People

Head of AI Data Development

Ram Shtoltz

Personally, I love being a part of a company that delivers such impactful and immediate, life-saving value to a countless number of patients. When a customer shares with me a “wow moment” he experienced with our product – it’s truly priceless.

Software Engineer

Lynne Hurwitz

Aidoc is the perfect combination of tackling a huge challenge, among extraordinary people, for a truly great cause. Everything we do eventually comes down to saving lives, and that’s an indescribable feeling.

DevOps Product Manager

Inbar Gabe

When the product you’re working on literally helps save lives – it doesn’t feel like work – it feels like true purpose. To be able to contribute to such a meaningful solution really does make me feel like a superhero every day!

Director, Customer Success - EMEA & APAC

Amitai Mandelbaum

To provide meaningful insights for radiologists and be given the opportunity to have a real impact on patients’ lives, daily, is beyond priceless. I still get goosebumps when a customer shares how we were able to help them make life-changing decisions for a patient.

VP of Finance

Barak Haimovich

Working with great people and being part of a team that provides such a valuable product is an awesome combination.

Commitment

To transform the world of healthcare with life-saving AI

Excellence

Veterans from elite technology units and leading engineering companies

One Team

Group of 400+ members that support each other like family

Open Positions

Aidoc is looking for extraordinary people to join our industry-leading team that’s building cutting-edge artificial intelligence to reshape the future of healthcare. Named one of TIME magazine’s “50 Genius companies”, an innovative and exciting work environment, talented teams and a great work culture are just a few of the reasons why you’ll love working here.

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Head of Regulatory Research (AI SaMD)

Tel Aviv

About The Position

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

About Aidoc

Aidoc is revolutionizing clinical decision-making with real-time clinical AI imaging solutions, impacting over 60 million patients annually. Our technology empowers physicians to diagnose urgent cases, ultimately improving patient outcomes.

Powered by our proprietary aiOS, Aidoc assists clinicians by precisely highlighting suspected pathological findings directly on medical images and prioritizing cases. This ensures that urgent patients receive the immediate attention they need.

As a leader in clinical AI, Aidoc has the most FDA-cleared Computer-Aided Detection (CAD) solutions, with adoption in more than 1,600 medical centers worldwide.

Since our founding in 2016, Aidoc has secured over $370 million in funding and was recognized as one of TIME’s 50 most genius companies.

About this role

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.

Responsibilities

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.

Requirements

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

Working at Aidoc

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