Director leading strategies for AI hardware and advanced compute solutions at HP. Collaborating with cross - functional teams to execute competitive market strategies.
About the role
- 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.
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.
Requirements
- 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
- 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
Job title
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