What are your main responsibilities? What does a typical week look like for you?
My main responsibilities include ensuring our product development follows the applicable regulations for any markets that we decide to sell in, and then ensuring that our quality management system remains ISO 13485 compliant. One key aspect of my role, especially in relation to our products, is ensuring that we follow regulations early in product development. For example, we're developing Atlas H&E-TME as a research tool in compliance with ISO 13485 and IVDR, so that it can be applied to clinical settings in the future.
In a typical week, I help ensure that our processes are actually meeting our needs and that we're following them. And also drafting regulatory requirements, putting together documentation and records for product releases, and then also auditing our teams to ensure that they follow the processes. When we identify gaps or areas for improvement, I also help to address whatever the issues are.
What is a recent challenge that your team overcame or a problem that you solved that you're particularly proud of?
Just a month ago we had our annual ISO 13485 surveillance audit, and I'm really proud of how we handled it. We performed really well, which was the result of a full year of preparation and proactive work.
The audit is essentially a comprehensive check of all the work we've done throughout the year to make sure our quality management system is running as smoothly as we hope. If we do identify issues during the audit, our team works with the process owners to get things fixed in a timely manner, identify root causes, and continuously improve.
The recertification process can be very stressful because we’re having all the work we've done evaluated across all teams. But it really showed how well our company communicates, within each team and across different departments. So I'm proud of how we managed it.
What is an impactful skill that you developed since joining the team that you did not expect?
I think for me, I'm learning a lot more and getting much more involved with software and model development than I was expecting, which has been really nice. It's given me the opportunity to work directly with the engineering teams to figure out how they actually build the software, what features they use, and how they write the tests. It's been incredibly educational.
What I've had to do is translate the work they're doing into process optimization. This means figuring out how we can use our systems like Jira or Ketryx to meet our regulatory requirements while still enabling the engineers to do the work they need to do. It's really about incorporating regulatory requirements into product development from the very beginning. That comes into play when writing the requirements themselves. During the planning phase of software development we know that clients will want specific features so the key is writing those requirements in a way that inherently meets the regulatory standards.
What is your favorite part about working at Aignostics?
This one is easy. For me, it's the people. I think our field is moving so fast. I've never seen a technological field that's just changing and evolving so quickly. This pace requires a lot of cross collaboration, and I enjoy working with the different teams. The people here are not only fun to work with but also willing to share their knowledge. I’ve learned a lot because of the collaborative spirit here.
I think what makes Aignostics special is that people are genuinely excited about the work we do and motivated to tackle issues or challenges together. Even though you're working on a big complex problem, it's exciting to be able to sit down and figure out how you're going to solve it together.
How would you describe your team in just three emojis?
📚⚡😌
The three I picked relate to the things that the regulatory and compliance team does the most.
📚 The first is educating the team. Spreading regulatory information and making sure that everyone understands the quality management requirements in every part of their job.
⚡ The lighting represents that we're always trying to evolve. I think a big part of the regulatory team is continuous improvement. Whether we're making reactive changes or proactive ones, we're always trying to make sure that change happens quickly.
😌 The last one represents our balanced approach to our day-to-day work. I think the regulatory team has a very focused and positive attitude to taking on challenges. Even when tackling complicated problems, we keep the atmosphere energetic and engaging.