Manager, Quality & Regulatory Affairs – Medical AI

deepeye Medical

Manager Quality & Regulatory Affairs managing ISO 13485 QMS processes in a medical AI startup. Guiding compliance strategy and collaborating with international teams for quality assurance.

Posted 4/27/2026full-timeMunich • 🇩🇪 GermanyMid-LevelSenior💰 €100,000 per yearWebsite

About the role

Key responsibilities & impact

Maintain and further develop our eQMS in accordance with ISO 13485
Advise senior leadership on global regulatory changes and their strategic business implications
Coordinate our network of country-specific consultants to ensure global compliance
Develop processes and policies that are easy for colleagues to follow

Requirements

What you’ll need

3+ years of experience: proven track record in managing and operating ISO 13485 QMS processes in the medical device industry
Hands-on experience with Software as a Medical Device (SaMD) and ISO 14971 risk management
Direct experience working with Notified Bodies, EMA and/or the FDA
Combination of critical thinking, precise written English, and a positive 'can-do' startup attitude
Master’s degree in a science, engineering, or health-related field is a plus
Experience in precision medicine, medical AI, or digital health is an advantage
Ability to translate complex regulatory requirements into actionable steps for the engineering team
German language skills are advantageous

Benefits

Comp & perks

Direct impact on improving the quality of life for patients and providers
Immediate ownership of your project and rapid personal growth
Flexible working hours, remote work, and an office in central Munich
Competitive compensation package, startup culture, and an international 'rockstar' team

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

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

Soft Skills

critical thinkingprecise written Englishpositive attitudecommunication