What regulatory topic do you consider your “sweet spot” and what do you wish people knew about it?
Somehow, the essence of regulatory affairs can be misunderstood. Regulatory affairs is about market access: does the device work, and is it safe enough? No more, no less. If an organisation reduces this to checking boxes, it will sooner or later end up in problems. Although I prefer helping companies demonstrate just those essentials, I keep ending up with companies that have to do that retrospectively and under severe pressure.
How did you get into regulatory affairs? What is your favorite part? What is your least favorite part?
I just stumbled into regulatory affairs. As an inspector for the Dutch competent authority, I had to dive into legislation. When I got involved in the first outlines of the MDR, I had to develop that touch and feel for legislation and how it works out in practice. When I started working for Emergo, I was able to use that experience to help clients become and remain compliant. I love the strategic side of this work, where we look into how to optimize all the steps that must be taken. I don’t like it when things are made unnecessarily complex. For example, if a notified body wants to discuss the exact qualifications of a PRRC, while they do not address what the PRRC is doing.
Why are you a regular RegEx user?
Almost daily, I check the RegEx forum to see if there are questions that I can help with. And sometimes I post a question myself.
What area of regulatory affairs would you like to learn more about?
Lately, I have been involved in drug delivery devices. My understanding of the requirements for medicinal products could be improved. Especially regarding the aspects that ‘everybody knows’ who works in that field, but that are not specified in legislation. Without being educated as a pharmacist, I sometimes have to look up very basic terms.
What is one thing you enjoy doing outside of work?
Outside of work, I like rugby. I still play every week, although that is no longer the full-contact version. I also like coaching children. Rugby is a game that combines physical activity with team skills. Individual weaknesses can be compensated for by using the strong points of team members. That is something that also works in real life, including regulatory affairs. After all, everybody knows something about medical devices, and nobody knows everything.