RAQM 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