We are a Berlin-based early-stage startup backed by leading investors and scientists on a mission to improve the lives of the 400 million people around the world who suffer from genetic diseases. The platform we have developed uses artificial intelligence and functional genomics to decipher how changes in the DNA of humans lead to disease. Through this platform, we enable genetic testing labs to provide clear and fast diagnoses to more patients.
For this, we've gathered one of the best teams of experts in genomics, artificial intelligence, and business development. Our people aren't just part of a team, they're part of something bigger. As a community of creative thinkers and doers, we're paving the way for a new generation of genetic healthcare.
We are looking for a Regulatory Affairs & Data Privacy Manager to take ownership of our regulatory & data privacy topics in a very critical role to the company’s future and help fulfil relevant national and international regulatory requirements. We have already been certified under IVDD and now looking for someone initially leading the IVDR certification process. Additionally:
You plan, coordinate and complete national and international medical device certification application processes and register our products in cooperation with our Product & Technology Teams
You are responsible for the certification process from approval strategy to documentation, in line with the medical device certification requirements (e.g. ISO standards, IVDR, FDA,)
You take care of regulatory & data privacy aspects in our interdisciplinary product teams
You maintain and review existing technical product files, e.g. for up-to-dateness and compliance
You take care of product-related risk management, from systematically identifying the current state-of-the-art to post-release risk analysis
You make sure that our products comply with all applicable global and regional regulatory requirements from labelling over performance to safety elements
We foster a flexible work environment and encourage applications from candidates that are either based in Berlin or would work remotely with a willingness to travel to Berlin occasionally.
You have several years of professional experience in the field of regulatory affairs of medical devices and experience with approval procedures in Europe/US
You have extensive experience in cooperation with notified bodies as well as respective health and approval authorities in Europe
You ideally have a Regulatory Affairs Certification (e.g. TÜV, etc.) or are keen to complete this with us
You have experience managing Data Privacy aspects
You have completed your university education in scientific or other relevant fields
You are highly communicative and able to manage information flows across departments and third parties
You enjoy working in a very accurate way and have a meticulous love for detail
You have a high affinity to high-tech products and MedTech
You have fluent English and German skills
Willingness to learn and openness to feedback
Experience in the cooperation with notified bodies as well as respective health and approval authorities in the US and/or China
Experience working in a software company
What we value in our team
Our team reflects the interdisciplinary collaboration required to solve this big challenge – ranging from software and data science to genetics and healthcare. We are a proudly diverse, international group of creative problem-solvers and humble learners that care about having a positive impact on society and are also aware of the trust placed in us. This is why we value transparency and kindness, taking ownership and we encourage your personal growth:
Develop your personal skills and knowledge with resources like books and courses to learn continuously
Dynamic and flexible work environment that you can design (incl. remote work options)
Participate in our success with equity options
Possibility to grow with the company, influence our direction and be part of the future of genetic diagnostics
Regular social activities (virtual & in-person): participate only if you feel like it
Additionally, we offer good coffee, a selection of healthy snacks and company-subsidized public transport in our Berlin office
We see diversity as a core feature of our team and we encourage you to apply especially if you are from an underrepresented group.