Manager, Quality & Regulatory Affairs – AI Medical Software

deepeye Medical

Manager Quality & Regulatory Affairs for AI Medical Software at deepeye Medical GmbH. Responsible for maintaining eQMS, advising leadership on regulatory shifts, and ensuring global compliance.

Posted 5/4/2026full-timeMunich • 🇩🇪 GermanyMid-LevelSeniorWebsite

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

3+ years' 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 (510(k)) or De Novo, and managing global compliance for new markets.
Mindset: A unique combination of critical thinking, precise English writing, and a positive, can-do startup attitude.
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 engineering teams; proficiency in German.

Benefits

Comp & perks

Direct impact on improving quality of life for patients and healthcare providers
Immediate responsibility for your projects and fast personal growth
Flexible working hours, remote work options, and office in Munich city center
Competitive compensation package, startup culture, and an international, high-performing team

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Hard Skills & Tools

ISO 13485ISO 14971AI Software as a Medical Device (SaMD)QMS processesrisk management

Soft Skills

critical thinkingprecise English writingpositive attitudecan-do mindset

Certifications

Master’s degree in scienceMaster’s degree in engineeringMaster’s degree in health