Regulatory Affairs Specialist

תיאור המשרה

About Aidoc Aidoc is the market leader in healthcare AI and has developed the world's largest clinical frontier model, supporting nearly 50 million patients each year. Aidoc is deployed in more than 2,000 medical centers worldwide. Since our founding in 2016, Aidoc has raised over $500 million and achieved a record number of FDA-cleared solutions. Medical diagnosis is hitting a breaking point, where the number of physicians hasn't kept up with the rapidly growing patient load. This leads to misdiagnosis and treatment delays that result in hundreds of thousands of deaths every year. Aidoc assists clinicians by precisely highlighting diseases directly on medical images, preventing misdiagnosis and ensuring that urgent patients receive the immediate attention they need. About this role We’re seeking a Regulatory Affairs Specialist to join Aidoc’s Regulatory team. In this role, you will support regulatory activities throughout the software development life cycle, including regulatory assessments, world wide registrations, regulatory submissions, and regulatory operations — ensuring our products meet international requirements and industry standards. Your expertise will directly advance the compliance, safety, and successful market access of cutting-edge AI healthcare solutions. Responsibilities • Regulatory Impact Assessments: Lead regulatory assessments of software changes and product enhancements, evaluating their impact on existing approvals, determining global regulatory requirements, and developing strategies to ensure continued compliance while enabling innovation. • Global Regulatory Submissions & Market Expansion: Own and drive end-to-end regulatory submissions and product registrations across international markets, including Canada, Australia, Brazil, and other key regions. Lead the preparation of submission dossiers, manage interactions with regulatory authorities, and respond to regulatory queries to secure timely market authorizations and support global business growth. • Product Labeling: Lead the creation, review, and maintenance of product labels in accordance with applicable regulatory requirements across global markets. Manage labeling updates, localization, and translation activities to ensure accuracy, consistency, and compliance throughout the product lifecycle.Promotional & Marketing Material Review: Partner with Marketing, Product, and Commercial teams to review and approve promotional, marketing, and customer-facing materials, ensuring that product claims are accurate, appropriately substantiated, aligned with authorized intended uses, and compliant with applicable regulatory requirements. • Write, update, and maintain technical files for class I and Class IIa products • Perform Regulatory operations activities , including handling significant administrative responsibilities related to global registrations and technical processes such as updating databases, dashboards, and trackers diligently. • Stay updated on new and changing regulations. • Translate regulatory requirements into actionable processes , enhancing efficiency, compliance, and product quality across the organization. • Cross-functional Collaboration: Work closely with SW engineers, data scientists, and product teams to identify testing requirements, troubleshoot issues, and ensure regulatory Compliance. Requirements Education & Experience • Bachelor’s degree in Engineering, Life/Exact Sciences, Quality Assurance or Law. • 1-2 years in regulatory teams within the medical device industry, preferably with SaMD (software as a Medical Device) - a plus . • Interest or background in computer science or AI - a plus . Skills & Qualities • Structured thinker with the ability to read and implement regulatory guidance and standards. • Analytical skills and data-driven decision making. • Exceptional project and program management skills. • Ability to work independently with minimal supervision. • Detail-oriented, proactive, and accountable. • English proficiency equivalent to a native speaker, with excellent verbal and written communication • Collaborative, team-oriented mindset with a passion for learning and growth. 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 Aidoc is deeply committed to creating an inclusive workplace, and to the principle of equal opportunity for all individuals. We prohibit discrimination and harassment based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other status protected by law.