Aiosyn is on a mission to accelerate the adoption of artificial intelligence in pathology with the potential to improve the chances of patients worldwide. We are a growing team of AI enthusiasts transforming state-of-the-art algorithms into certified medical devices that can be used anywhere, anytime. Our AI solutions will benefit millions of patients in pathology diagnostics worldwide.
We are looking for a highly motivated individual regulatory affairs specialist who will drive Aiosyn’s regulatory strategy and wants to be part of a vibrant team with a common goal to pioneer AI in pathology. If this sounds exciting to you, come and join us!
We’re looking for a specialist with 3+ years of demonstrable RA experience in the Software Medical Device industry. As we develop new products, you will lead and further build the regulatory activities at Aiosyn.
What your responsibilities would look like
- Responsible for regulatory compliance and registering Aiosyn’s medical devices.
- You will drive the effort to build the technical files of Aiosyn’s devices, supported by the technical and clinical team members.
- Obtain the relevant regulatory clearances in line with Aiosyn’s strategy (CE-IVDR, FDA clearance, UKCA, etc.).
- Register as Aiosyn’s regulatory compliance representative, e.g., PRRC under the IVDR.
- Liaise with notified bodies, competent authorities, and other relevant organizations to ensure a high-quality and efficient approval process.
- Report directly to the management team.
- As a member of our regulatory team, you will work closely with our QA and clinical experts.
- Support our teams in all steps of the development and validation process, including product design, clinical evidence collection, and post-marketing activities.
- Actively developing regulatory affairs processes to boost efficiency.
- Identify and help resolve product development issues that impact regulatory submission activities.
What your background looks like
- University degree equivalent to a Master’s education in a relevant field.
- Experience in the field of Software as a Medical Device (SaMD).
- Knowledge of the In-vitro Diagnostic Devices Regulation (preferred) or Medical Devices Regulation
- Hands-on expertise with CE or FDA approval trajectories. For example, experience in submitting a technical file.
- Knowledge of quality standards such as ISO13485, IEC62304 and ISO14971.
- Knowledge/experience in GDPR, HIPAA or ISO27001 is a plus.
- Strong communicator and good project manager in leading discussions regarding the safety and efficacy of medical devices.
- A purpose-driven personality that wants to make an impact on healthcare.
What we offer
- An exciting, fast-paced position, with a lot of growth potential, in an exciting medtech startup.
- An opportunity to lead others, learn by doing, grow with the team, and be the best version of yourself.
- You will be a core member of our regulatory team, working with team members focusing on QA and clinical evaluation.
- 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 impact what we do.
- A welcoming atmosphere with a positive vibe, where work-life balance is a priority.
- Flexible working hours, the possibility of part-time working from home, 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!
- We are looking for a full-time extension to our team (32-40 hours).
- Your primary place of work will be our office in Nijmegen, with the option of part-time working from home.
- You must be either living in the Netherlands or willing to move to the Netherlands.
Aiosyn B.V. is an equal opportunity employer and dedicated to creating a workplace that is free of harassment and discrimination. We base our employment decisions on business needs, job requirements, and qualifications. We do not discriminate on race, gender, religion, health, personal beliefs, age, family, or parental status, or any other status.