Senior Regulatory Affairs Specialist (Medtech)

TL;DR

Senior Regulatory Affairs Specialist (Medtech): Leading technical documentation and notified body submissions for a clinical AI assistant with an accent on MDR and the EU AI Act. Focus on building regulatory processes, ensuring compliance with medical device standards, and enabling market access across European healthcare systems.

Location: Hybrid in Amsterdam, Netherlands

Company

Kaiko is building a next-generation agentic clinical AI assistant that helps clinicians reason across patient data, guidelines, and diagnostics.

What you will do

• Lead the execution of regulatory strategy under MDR and EU AI Act.
• Own full technical documentation for notified body submissions and maintain it throughout the product lifecycle.
• Respond to regulatory authority inquiries and prepare necessary notifications and consultations.
• Act as the primary regulatory point of contact for engineering, product teams, hospital partners, and public tenders.
• Collaborate with the Compliance Management System manager to maintain the QMS in line with ISO 13485, ISO 14971, and IEC 62304.

Requirements

• 5+ years of experience in regulatory affairs within medical devices, specifically in digital health, health AI, or Software as a Medical Device (SaMD).
• Hands-on experience with MDR (EU 2017/745), technical documentation submission, and Notified Body interactions.
• Ability to translate complex regulatory requirements into actionable guidance for technical teams.
• Strong verbal and written communication skills for authoring technical regulatory documentation.
• Experience in AI/ML-based product environments is strongly preferred.

Culture & Benefits

• Competitive salary and a comprehensive pension plan.
• 25 vacation days per year.
• EUR 1,000 annual learning and development budget.
• Annual commuting subsidy.
• High degree of autonomy and flexible work arrangements.
• Regular offsites and team events.

Hiring process

• Screening call with Recruitment to align on motivation and values.
• Introductory interview with the Hiring Manager focusing on background and problem-solving.
• Technical interview and final conversation with the executive team regarding long-term alignment.