Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist About kaiko.ai Kaiko is building a next-generation agentic clinical AI assistant that helps clinicians reason across patient data, guidelines, and diagnostics. Healthcare decisions are rarely made by a single person or from a single data source. kaiko's assistant maintains longitudinal patient context across encounters, clinicians, and institutions, enabling collaboration, second opinions, and complex diagnostic workflows. The system is designed to operate safely in real clinical environments, with human oversight, auditability, and regulatory alignment at its core. Our assistant core supports broadly applicable clinical tasks such as patient data navigation, guideline interaction, multimodal interaction (chat and voice), and care coordination. On top of this foundation, we are developing specialized diagnostic agents in areas such as oncology, radiology, and pathology. We build in close collaboration with leading hospitals and research centers, including the Netherlands Cancer Institute (NKI). kaiko is a well-funded company with a growing international team, operating from Zurich and Amsterdam. Role overview As Senior Regulatory Affairs Specialist, you will own the technical documentation and notified body submissions. You will lead the execution of the regulatory strategy, and serve as an internal expert on MDR and the EU AI Act, guiding product, engineering, and clinical teams to ensure Kaiko’s solutions meet the highest regulatory standards as the company scales across European healthcare systems. This is a foundational, high-impact role. You will be building and maturing regulatory processes in a fast-moving clinical AI environment, with direct influence on product strategy and market access. Key responsibilities Regulatory affairs: • Lead the execution of regulatory strategy under MDR and EU AI Act. • Own the full technical documentations for notified body submission, and sustainment during the product lifecycle • Respond to regulatory authority inquiries and prepare submissions, notifications, and consultation responses • Monitor regulatory changes and assess their impact on existing and pipeline products Cross-functional & Strategic: • Act as the primary regulatory point of contact for engineering team, product team, hospital partners, procurement teams, and public tenders • Work closely with the Compliance Management System manager on building and maintaining kaiko’s Quality Management System (QMS) in line with MDR, AIA, ISO 13485, ISO 14971, IEC 62304 Requirements Experience: • 5+ years in regulatory affairs within medical devices, including the experience in digital health, or health AI, and Software as a Medical Device (SaMD) • Hands-on experience with MDR (EU 2017/745), including technical documentation submission and Notified Body interactions • Experience in AI/ML-based product environment strongly preferred Skills & Attributes: • Ability to translate complex regulatory requirements into clear, actionable guidance for engineering , product and clinical teams • Collaborative, pragmatic, and comfortable working with ambiguity • Strong verbal and written communication — able to independently author and review technical regulatory documentation Why kaiko At kaiko, we believe the best ideas come from collaboration, ownership, and ambition. We've built a team of international experts where your work has a direct impact. Here's what we value: Ownership : You'll have the autonomy to set your own goals, make critical decisions, and see the direct impact of your work. Collaboration : You'll approach disagreement with curiosity, build on common ground, and create solutions together. Ambition : You'll be surrounded by people who set high standards for themselves and others, who see obstacles as opportunities, and who are relentless in their work to create better outcomes for patients. In addition, we offer: An attractive and competitive salary, a good pension plan, and 25 vacation days per year. Great offsites and team events to strengthen the team and celebrate successes together. A EUR 1000 learning and development budget to help you grow. Autonomy to do your work the way that works best for you, whether you have a kid or prefer early mornings. An annual commuting subsidy. Our interview process Our interview process is designed to assess mutual fit across skills, motivation, and values. It typically includes the following steps: Screening call with Recruitment : A short conversation to align on your motivation, professional goals, and values-fit. Intro with the Hiring Manager : A deep dive into your background and problem-solving approach, and a good moment to learn more about the day-to-day scope of the role. Technical interview and final executive conversation : A chance to showcase your knowledge and a final discussion with a member of the executive team focused on long-term alignment and shared expectations for impact. Locations Amsterdam Remote status Hybrid Amsterdam