In this new mini-series, we went behind the scenes to chat with Elly Gysels, Head Regulatory Affairs at Sensile Medical AG in Solothurn, Switzerland.
A Day in the Life of a Head of Regulatory Affairs
My name is Elly Gysels, I live in Switzerland, but I’m from Belgium originally. I moved from one chocolate country to another.
I’m head regulatory affairs at Sensile Medical, a Gerresheimer company.
What Does the Role of a QA/RA Entail?
I’m responsible for getting the drug delivery devices we develop approved in the target countries. These approvals build on demonstrating the safety of the device for patients and other users as well as the performance of the device and its clinical effectiveness.
In order to ensure a smooth approval process, I take care of the regulatory aspects of our direct delivery devices from feasibility stage throughout development.
This requires strategic work writing regulatory deliverables, reviewing product documentation, tracking regulatory risks, participating in meetings with, for example, the FDA and addressing requests from authorities like conformity assessment bodies.
Also, when a device is on the market, continued compliance with regulatory requirements needs to be insured.
How do You Stay Up to Date with QA/RA Regulations and Trends?
I read newsletters, participate in training events, workshops and external meetings with regulatory affairs professionals. I always stay up to date with the regulations, standards and guidance documents.
And last but not least, I line manage a fantastic team of regulatory affairs managers and technical writers.
Why did You Choose This Career Path?
I chose to work in medtech ever since I graduated because I find the possibility to contribute to patients’ quality of life meaningful.
I love regulatory because it involves writing and getting the writing right is important.
I like the challenges as well as the complexity and the dynamic aspect of these interesting fields.
Being head allows me to be more involved in the decision making and contribute on a different level.
As a line manager, I hope to make a difference for my team.
What Does a Typical Day/Week Look Like for You?
A lot of meetings; project related meetings, team meetings, management meetings. Hands-on work on projects and product documentation as well as processes, preparing and holding presentations. For example, for information or training purposes.
I also take time to stay up to date on changes in the regulatory space and work on topics that are important in the longer term.
What Inspired You to Become a QA/RA in Medtech?
My focus has always been doing something I find meaningful and very much like doing, and I seized interesting opportunities that came my way.
Tell Us One Thing That You Wish you Knew Before
I wish I had known earlier what regulatory entails and how interesting it is. That said, there are many things I learned in my previous roles and it certainly helps to see the bigger picture bring different pieces together.
What is the Most Common Myth Associated with Working in QA/RA?
That our mission is to annoy people. The truth is, we want to get an innovative product to market as smoothly as possible and prevent frustration later on.
What do You Love About Your Role?
The variety in my tasks, the different types of multidisciplinary projects I have the chance to work on and the great people I work with across disciplines, hierarchy levels and geographical locations.
What is One Thing That You Would Change About Your Role?
That’s a difficult one. Having a bit less meetings maybe.
What Advice Would You Give to People Who Want to Become QA/RAs?
If you like the challenge of a fast and dynamic field, if you like a good mix of writing and reviewing, working in multidisciplinary teams, management tasks, then by all means, go for it.
What Three Things do You Need to Have in Order to be Successful in This Role?
I’d like to mention three groups of skills:
- Analytic and synthetic skills.
- Seeing the bigger picture – thinking ahead, connecting the dots.
- Excellent Communication skills.
Biggest Challenges of This Role?
Striking a balance that satisfies all stakeholders; both internally and externally.
What's the Best Career Advice That You Ever Got?
Make sure your job fits with what’s important in your life.
The one I would like to give is to do something you very much like doing. The passion and enthusiasm that comes with it will be of great value.
Who is Your Greatest Role Model?
There are many people I encounter that have been great examples and that I could learn from. I’m grateful to all of them.
Goals for 2021
Get innovative products to patients and have fun all the way.