Business Administrator: Regulatory Affairs

vor 3 Wochen

Heidelberg, Deutschland living brain GmbH Vollzeit

living brain is an award-winning med-tech start-up that brings neurotherapy to the next level. We create personalized, science-based 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 high-functional MDR-certified 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.

That's why we are now looking for a part-time 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 company-wide 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 Bachelor’s 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 detail-oriented mindset with strong analytical and problem-solving 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 - it’s 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 QM-system 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 in-house
  • 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 "no-bullshit-policy" - 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 Year's Eve are free: The Christmas holidays and the days between Christmas and New Year's 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 don’t 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

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