Manager Quality & Regulatory Affairs for AI Medical Software - (w/d/m)

What we are doing

Our mission is to prevent vision loss and ultimately blindness by developing AI software that assists eye doctors in therapy planning for their patients. We use computer vision deep learning models (AI) trained on thousands of cases and millions of images to predict disease progression, individualize therapy and improve outcomes. The decision support algorithm targets widespread eye diseases like Age-related Macular Degeneration (AMD, 7.5mio affected in Germany alone).

Your responsibilities

• You will maintain and evolve our eQMS in accordance with ISO 13485 and steer all internal and external audits.
• You will act as a primary advisor to leadership on global regulatory shifts and their strategic impact on our business.
• You will orchestrate our network of country-specific consultants to ensure global compliance.
• You are great in your job when your colleagues follow your processes and guidelines, because they understand it makes their lives easier in the long run

Your must-haves

• 3+ Years of Experience: Proven track record in managing and operating ISO 13485 QMS processes within the medical device industry.
• Hands-on AI SaMD: Practical experience with AI Software as a Medical Device (SaMD) and ISO 14971 Risk Management.
• Regulatory Authority Interaction: Direct experience working with Notified Bodies, EMA, FDA (510K) or DeNovo, and global compliance for new markets.
• Mindset: A unique combination of critical thinking, precision writing in English, and a positive, "can-do" startup attitude.

Your nice-to-haves

• Master’s degree in science, engineering or health
• Experience in precision medicine, medical AI or digital health
• Ability to translate complex regulatory requirements into actionable steps for the engineering team
• Proficiency in German