RA/QM Manager MedTech

Our client is highly innovative and using AI technologies to improve the workflow in the oncology field. Their AI-driven SaaS solution recently passed through the medical device certification process for MDR and launched in 2021.

Join this tight-knit, highly diverse and very international team of data scientists, software engineers, and both medical & business professionals on improving patient outcomes worldwide as their next RA/QM Manager.

 

Responsibilities:

 

  • You can systematically develop and expand your Regulatory Affairs Management department in our young tech startup
  • Here you accompany the new and further development of our products on the regulatory side
  • For our employees and business partners, you are a trustworthy contact for regulatory issues
  • You support us in combining the regulatory requirements and quality standards from the medical device world with the dynamism of an innovative AI start-up
  • You know how to fill your area of ??responsibility self-effectively with expertise and drive
  • You can follow regulatory changes and convey them communicatively
  • Together with us you realize the approval as a medical device class IIa according to MDR

 

Who we are looking for:

 

  • You have successfully completed an engineering or natural science degree
  • You have already gained several years of experience in regulatory affairs at a medical device manufacturer, preferably in the approval of medical devices and with QM systems (ISO 13485)
  • In the best case, you also have an experience-based understanding of standalone software / tech startups
  • An independent and goal-oriented way of working is a matter of course for you
  • Your communication and negotiation skills underline your appearance
  • Very good written and spoken German and English skills complete your profile

 

To discuss this role and further opportunities in Regulatory Affairs, please contact Rebecca Stevens at Rebecca.Stevens@adaptivelifescience.com