Senior Regulatory Affairs Specialist
About us
Kaiko is actively developing a next-generation autonomous clinical AI assistant that supports clinicians in analyzing patient data, guidelines, and diagnostics. The company works closely with top hospitals and research centers, including the Netherlands Cancer Institute (NKI), to create solutions that improve healthcare decision-making and patient outcomes.
Job description
As a 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 that directly influences product strategy and market access.
- 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
- 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
Relevant work experience
- 5+ Years in Regulatory Affairs within Medical Devices, Including Digital Health, 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
Benefits
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
Skills required for the job