Title

Head/Director of Regulatory Affairs for our AI-powered in vitro diagnostic SaMD.

Company Overview

At hema.to our vision is that every patient receives an accurate diagnosis as early as possible, to enable the optimal treatment for everyone’s unique immune system. We do this by building clinical-grade AI cytometry as a Software as a Medical Device (SaMD) regulated under the IVDR, designed to improve patient outcomes and streamline clinical workflows. Backed by a passionate team of technologists, clinicians, and business experts, we’re redefining how blood diagnostics are developed, validated, and delivered.

The Opportunity

We’re looking for a Head/Director of Regulatory Affairs to spearhead our regulatory strategy across multiple IVD products, including the CE-IVD and FDA approval pipelines. You will partner closely with cross-functional teams (Product, Clinical, QA/RA, Tech) to ensure our solutions meet global regulatory standards. This is a unique opportunity to shape and execute the regulatory vision at an early-stage startup poised for rapid growth and lasting impact.

Key Responsibilities

• Strategy & Leadership:
  • Define and lead regulatory strategy for CE-IVD marking and FDA submissions.
  • Oversee the lifecycle of regulatory approvals, ensuring alignment with the company’s product roadmap.
  • Provide high-level guidance and governance to cross-functional teams on regulatory compliance.
• Regulatory Submissions & Compliance:
  • Manage regulatory submissions for EU, FDA, and other international markets.
  • Maintain oversight of clinical evaluation, risk management, and technical documentation.
  • Guide teams through compliance with ISO 13485, MDCG guidelines, and other relevant standards.
• Cross-Functional Collaboration:
  • Work closely with R&D, Product, and Quality teams to align development processes with regulatory requirements.
  • Serve as the internal expert for regulatory best practices and emerging policies.
• Team Building & Mentorship:
  • Mentor and grow our internal regulatory affairs team.
  • Develop scalable processes that can adapt as the product portfolio and team expand.

Qualifications

• Experience: Approximately 10 years of Regulatory Affairs experience, with a proven track record in IVD and SaMD.
• Must-Have:
  • Demonstrable success in leading CE-IVD and/or FDA submissions (SaMD experience is a must).
  • Deep knowledge of quality management systems (ISO 13485) and relevant regulations (MDR/IVDR, 21 CFR Part 820).
  • Strong project management and leadership skills with a hands-on approach.
• Soft Skills:
  • Exceptional communication skills in English (oral and written).
  • Strategic mindset with the ability to manage ambiguity and shifting priorities.
  • Collaborative nature, comfortable working with cross-functional, global teams.

Location & Working Arrangements

• We are headquartered in Munich, but remote candidates within reasonable time zones are welcome.
• Flexibility to travel to Munich for critical meetings or team events as needed.

Why Join Us?

• Impact & Ownership: Shape the regulatory function at a pivotal stage of company growth.
• Innovative Culture: Work with a diverse, cutting-edge team driven by a common mission.
• Competitive Compensation: Salary range commensurate with experience, plus equity options (details TBD).
• Growth & Development: Opportunity to build out and lead a key function with significant autonomy.

How to Apply

Please submit your resume outlining your relevant experience and vision for regulatory affairs in an innovative IVD/SaMD environment to our CEO Karsten using this link. We look forward to exploring how your expertise can power our next stage of growth!

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