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Working Student (m/f/d) – Quality Management & Regulatory Affairs

Working Student (m/f/d) – Quality Management & Regulatory Affairs

Working Student (m/f/d) – Quality Management & Regulatory Affairs

Working Student (m/f/d) – Quality Management & Regulatory Affairs

Caire Health AI GmbH

Internet, IT

München

  • Art der Beschäftigung: Studierende
  • Vor Ort

Working Student (m/f/d) – Quality Management & Regulatory Affairs

Über diesen Job

Working Student (m/f/d) – Quality Management & Regulatory Affairs

About Caire

At Caire.ai, we are building intelligent, contactless health monitoring solutions that enable medical professionals and patients to measure vital signs effortlessly through video-based technologies. As a growing MedTech startup based in Munich, we combine artificial intelligence, regulatory compliance, and medical expertise to deliver innovative software medical devices.

We are looking for a motivated Working Student (m/f/d) to support our Quality Management and Regulatory Affairs team. If you’re passionate about medical device technologies, eager to learn about regulatory processes, and want to make an impact in a dynamic environment—this is the place for you!

Responsibilities

  • Support the Quality Management team in continuously improving the Quality Management System (QMS) in accordance with ISO 13485 and EU MDR.
  • Assist the Regulatory Affairs team in the creation, review, and maintenance of Technical Documentation for medical device software according to EU MDR.
  • Prepare and participate in internal and external quality audits.
  • Conduct ongoing research on regulatory updates and standards relevant to medical device development in Europe and other markets.

Qualifications and Skills

  • You are currently pursuing a degree in a scientific or engineering field, ideally with a focus on medical device technologies or regulatory affairs.
  • You have prior experience or coursework in risk analysis, requirements management, medical device regulations.
  • You are detail-oriented, well-organized, and approach challenges with a structured mindset.
  • You are interested in medical device technologies, software as a medical device (SaMD), and the regulatory landscape.
  • You possess excellent English communication skills (written and spoken); German is a plus.

What we offer

  • A learning-oriented environment where you can quickly develop your skills in medical device quality and regulatory affairs.
  • The opportunity to work in a fast-paced startup where your contributions have an impact from day one.
  • A dynamic and international team with an office in a prime Munich location (Ostbahnhof).
  • Hybrid working model with flexibility and autonomy.

Interested?

Send your CV and a short motivation letter to mohtadi.benfraj@caire.ai with the subject line:

Working Student – QM & RA

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