Regulatory Affairs Manager (m/w/d)


We are looking for a passionate Regulatory Affairs Manager to join our cross-functional team and not only take on exciting regulatory projects, but also take our customers to a new digital level. We work in a highly innovative way and help medical device manufacturers to digitalize regulatory processes with our software.

What we offer
  • Good payment
  • Permanent position (full or part time possible)
  • 30 days vacation
  • Work where you want: at home or mobile
  • Flexible working hours
  • Top modern digital infrastructure
  • Fast decision-making due to flat hierarchy
  • Young startup team
What are our values?

We are a young company with the urge to grow. Empathy and respectful interaction are very important to us in our daily work. Working for us should be sustainable and family-friendly for you. We approach our challenges courageously, with an eye on ethical justifiability. We talk openly about successes and failures, reproach-free about problems and find solutions together. Everyone is welcome on our team and we look forward to your application!

What tasks do you get?
  • Responsible projects that lead medical device manufacturers into the digital age
  • Solving regulatory challenges of our customers
  • Participation in the design of our software solution for Regulatory Affairs - meddevo eTD
What do you bring?
  • Completed engineering studies (medical technology, or comparable)
  • Experience with EU-MDR or EU-IVDR, ISO 13485
  • Experience with technical documentation for medical devices
  • The will to establish and develop modern digital solutions in medical device industry
  • Confident German and English skills
  • Independent work
  • Strong teamwork and communication skills
What do we want beyond that?
  • Optional: Experience with ISO 14971, 10993-1, 60601, IEC 62366-1, Clinical Evaluation, Performance Evaluation
  • Affinity to digital solutions

Apply now!

Have we piqued your interest? This is how it goes now:

  1. Send us your application documents to
  2. We confirm the receipt and look at them
  3. We arrange a first appointment to get to know each other (remote)
  4. Technical interview with one or more team members (remote)
  5. We will send you a draft contract and look forward to your commitment and cooperation with you

Do you have any questions?


Markus Falk


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