This autumn, you joined the RegSmart team as senior consultant medical device and IVD.
Tell us, what is your background prior to joining RegSmart?
I have a PhD in pharmaceutical sciences but instead of pursuing an academic career, I started my own consultancy business. Consultancy suited me well, and for the last decade I have provided regulatory advice and interim management services to medical device manufacturers.
During the recent pandemic, I served as COO for one of the private labs that provided covid-19 diagnostic testing for the regions. As my main expertise is in diagnostics (IVD) and genetic testing the opportunity to work on the user side and with in-house production of diagnostic devices gave me a lot of valuable insights on how these types of products may be managed.
All in all, many of the projects I have worked on both as a student and since have been aimed at improving diagnostics for prostate cancer patients, so this patient group has a special place in my heart.
What are your strengths, and how do you contribute?
My superpower is curiosity!
Regulators strive to keep up, but in the end science and technology are always going to be at least one step ahead of current legislation. New and innovative products sometimes end up in the grey area between legal frameworks or where two or more regulations overlap. Those are my favorite products to work with.
In the current transfer from MDD/IVDD to MDR/IVDR there are new requirements, harsher scrutiny, and a lack of prejudices to rely on for interpretations. Here, I believe I can help manufacturers with legacy products understand and bridge the gap between IVDD and IVDR.
What are you looking forward to?
Well, right now everything is new and sparkly! New projects, new colleagues, new challenges… I feel equally enthusiastic and grateful to get the opportunity to learn from the incredibly experienced team at RegSmart. Hopefully, my niche of regulatory expertise and small business perspective will be a valuable addition to the team.
”Welcome to RegSmart Jennie! Your experience, knowledge and perspective will be a great contribution to the RegSmart team!” says Mats Högberg, Director medical device and IVD, RegSmart.