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!
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