Vacancy

Regulatory Affairs Specialist

Aiosyn is looking for a highly motivated individual to pilot our regulatory strategy, and have a profound impact on the products we are developing.

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About Aiosyn

Aiosyn is on a mission to accelerate the adoption of artificial intelligence in pathology diagnostics to improve the chances of cancer patients worldwide. If this sounds exciting to you, come and join us!

We are a growing team of AI enthusiasts transforming research algorithms into fully-fledged CE-IVD certified medical devices. Our AI solutions will benefit millions of patients in pathology diagnostics worldwide. We are looking for a highly motivated individual to pilot our regulatory strategy, and have a profound impact on the products we are developing.


What your responsibilities would look like:

  • Implement a company-wide Quality Management System that complies with ISO13485.
  • Manage technical documentation and regulatory submissions.
  • Register as Aiosyn's regulatory compliance representative for authorities such as notified bodies.
  • Manage the process of obtaining CE-IVD marking for our AI solutions for pathology diagnostics.
  • Support the team in designing clinical trials aimed at collecting evidence to demonstrate the clinical performance of our devices.


What your background looks like:

  • University degree equivalent to Master’s education in a relevant field.
  • Minimum of 3 years of work experience.
  • Proven track record in managing a Quality Management System.
  • Familiar with quality standards such as ISO13485 and ISO27001.
  • Experience with the In-vitro Diagnostics Regulation (IVDR) in Europe.
  • Plus: knowledge of the medical device regulatory landscape in the United States (FDA).


What we offer:

  • An exciting, fast-paced, senior position in a thrilling medtech startup.
  • A good purpose: our products will help doctors to assess complex diseases like prostate or breast cancer, for the benefit of patients and society.
  • A very flat work hierarchy where your opinion will always be listened to, and will have an impact on what we do.
  • A welcoming atmosphere with a positive vibe, where work-life balance is a priority.
  • An opportunity to lead others, learn by doing, grow with the team, and be the best version of yourself.
  • Flexible working hours, possibility of remote work, and a cool office situated on the university campus surrounded by green areas in Nijmegen.
  • A competitive salary, and 25 holidays per year (plus additional public holidays).
  • Startup perks: fresh drinks&food, walking lunch in the botanical garden, table tennis championship, pizza&beer evenings, bowling nights, next-door sports facilities, and much more!

How to apply?

If you feel excited about the journey ahead of us, please apply now! To apply, send your motivation letter and CV to hiring@aiosyn.com.