Regulatory Affairs Manager – Join an Innovative, Growing Team

  • Berlin, Berlin, Germany

Regulatory Affairs Manager – Join an Innovative, Growing Team

Job description is a Berlin-based startup that revolutionizes dentistry with state-of-the-art artificial intelligence technology. We offer a decision support platform that helps dentists detect pathologies and anatomical structures on dental imagery such as x-rays. For the dentist, the advantages are time savings, better treatment decisions, and improved patient trust.

You will be one of the early employees, having a major impact, shaping the company through your efforts and industry expertise. Together, we take years of academic research in dentistry and machine learning and bring them to industry. Our team is made up of engineers, scientists, entrepreneurs, and physicians from one of the world's leading hospitals. Our hierarchy is flat and communication direct, which means that we operate and learn fast, as a team.

You will join our team as a Regulatory Affairs Manager. In this role you will plan and execute our strategy for certifying our medical software for multiple markets. In the past, we worked with a consulting company to help us manage our certification process. Now, we want to add this core competency to the heart of our team. We plan to get a medical device certification this year, we plan to further develop our existing medical product and release additional medical products.

Your role:

  • Introduce and continuously improve our Quality Management System
  • Write the technical documentation (together with our engineering team) for the CE certification
  • Help identify potential risks, raise awareness for safety concerns, and plan risk mitigations
  • Plan and manage the CE certification of our medical devices
  • Collaborate with European legislators to improve best practices for the healthcare products containing artificial intelligence

Job requirements

Your Qualifications:

  • BA/BS or practical experience of at least 3 years in business, computer science or a related field
  • Business fluent in the English and German language
  • Experience with Office Software
  • You enjoy enhancing the structuring of our processes and associated documentation
  • Structured, independent work
  • Open-minded and communicative

Preferred Qualifications:

  • MS or PhD in business, computer science or a related field
  • Experience in project management
  • Experience with Quality Management Systems according to ISO 13485
  • Instruct, contribute to, and review the writing of technical documentation of our medical device software products
  • Related industry experience for certifying a product
  • Passion for technology
  • Experience in technical writing
  • Experience with version control systems like git
  • Experience with testing software or quality assurance techniques

The preferred qualifications are just that: preferred. None of us walked in with all of them. If a few of these points apply to you, we definitely want to talk! You will get on-the-job training for all the needed qualifications.

Why you’ll love working here:

  • You work in a small to mid-size team with independent but cooperative mindset
  • We have regular team events that you are invited to join, but don’t have to.
  • As we are just at the beginning of our journey, we want you to shape our work environment with us.

In addition to a competitive salary you can expect the following: 

  • On-the-job training / educational courses: Certifying AI products is a very new field. We cover all training for you to develop skills/knowledge.
  • Work within a good network of medical and regulatory experts
  • Flexible working hours (also remote days are possible) as we believe in ownership and trust
  • Smart and motivated team based in Berlin
  • Professional dentist check-up :)

How to Apply:

Your application should include:

  • Your resume
  • A cover letter 
    • Explain why you are the ideal candidate for this role.
    • Briefly mention your salary expectations.

We embrace diversity and inclusion and provide a safe and welcoming environment to everyone: Come as you are!