Business Administrator Regulatory Affairs fmd part-time

living brain is an awardwinning medtech startup that brings neurotherapy to the next level. We create personalized sciencebased and fun therapy for people with neurological diseases. To get there we combine virtual reality the latest research and gamification.

We believe that every patient deserves the perfectly adapted and functional rehabilitation that is needed. And we are passionate about providing that.

We are proud to say that with teora mind we developed the first highfunctional MDRcertified medical software for VR neurorehabilitation in Europe. Our clinical trail shows that teora mind outperforms the current gold standard method significantly.
Our next step is to bring our product into the world and bring a new standard of care to those in need.

Thats why we are now looking for a parttime Business Administrator: Regulatory Affairs who makes sure our products meet stringent regulatory standards and requirements while also providing valuable support to management in legal and regulatory matters.

Tasks

• stay informed about evolving regulatory requirements in the European and US markets including MDR FDA and GDPR
• interpret and apply relevant harmonized standards and norms to ensure regulatory compliance
• manage and maintain our Quality Management System in line with ISO 13485 standards
• prepare and update our technical documentation for our software as a medical device (risk class IIa) in accordance with MDR
• carry out internal and external audits (e.g. with notified body) identifying areas for improvement and implementing corrective actions
• take care of our risk management
• provide support to management by researching various law and regulatory topics to ensure companywide compliance
• assist in the review of legal contracts scanning for mistakes and errors before they are processed by legal counsel

Requirements

Minimum Requirements:

• You have a Bachelors degree in a relevant field (e.g. Regulatory Affairs Biomedical Engineering Life Sciences).
• You have very good communication skills and are fluent in German and English (verbal & written)
• You have proven experience in regulatory affairs within the medical device industry.
• Your social competence your ability to work in a team and your independent and structured way of working is what makes you the perfect fit.
• Your detailoriented mindset with strong analytical and problemsolving abilities sets you apart.
• You work independently and manage multiple projects simultaneously.
• You see yourself as an allrounder who is curious about different law & regulatory topics.

Nice to have:

• You are familiar with ISO 13485 and other relevant quality management standards.
• Your prior experience with software as a medical device.
• Your experience with Atlassian / Confluence.

Benefits

• arrange your working hours flexibly
• work remote or have your own seat in our office in the beautiful city of Heidelberg its up to you.
• contribute your ideas and take responsibility for your projects to contribute to the growth of the company
• receive all the hardware you need to show off your best performance
• work in a medical device company with fully digitized QMsystem and technical documentation no paperwork!
• be part of a company where the management values the quality management and is familiar with the associated standards as the QMS has been developed entirely inhouse
• get insights into the latest neuroscientific findings and technologies and be part of the neurotherapy of tomorrow!
• work in a young highly motivated team with a nobullshitpolicy where the best idea and not the position counts!
• become part of a meaningful company and make the world a little bit better with your work
• Christmas & New Years Eve are free: The Christmas holidays and the days between Christmas and New Years Eve are always free days for us. We do not deduct these days from your holiday entitlement. They are considered company holidays.
• and last but not least of course experience the obligatory startup culture with pizza gaming events and free drinks!

We encourage you to apply for this role even if you dont match all the requirements 100%. As long as you inherit the eagerness to learn we are happy to be convinced that you are the right fit for us.
We are looking forward to you and your application!