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