On June 1, you joined the RegSmart team as Director medical device and IVD, with a senior consultant role.
Tell us, what is your background prior to joining RegSmart?
I am a senior executive with global experience in the medical technology and life sciences market. Over the past 30+ years, I have worked in several international corporations and started two life science companies. My scientific background is medical engineer and I have a M.Sc. in Industrial marketing and commercial law from Uppsala University, where I also went through an Executive MBA.
Most recently, I worked as CEO for Pharmacolog AB (publ), listed on Nasdaq First North. Pharmacolog is a MedTech company, specialized in providing tools and solutions for medication efficacy in personalized medicine.
My career started at Scanditronix AB where I held various sales and marketing positions. After several management roles in other corporations, I became Managing Director for Nucletron Scandinavia AB. At Nucletron, I also held various commercial and general management roles, including the one as Marketing Director EMEA at Nucletron B.V. Prior to my assignment in Pharmacolog, I held a Vice President position at Elekta AB (publ).
What are your strengths? How do you contribute?
Having worked for more than three decades in organizations that are in the absolute forefront of new medical technology have taught me many things. There are two particular learnings that will be very valuable in my role here at RegSmart: first a good ability to understand complex technology and how it can affect current clinical settings, and second the experience how to build and implement an appropriate regulatory strategy and quality system. Besides that, I have a true passion for helping companies and entrepreneurs bringing new innovations to the market and improve patient care. My ambition is to support them with expertise in defining intended use, choosing the right regulatory strategy as well as a pragmatic implementation of a quality system. Factors that are key to a cost-effective certification and to shorten time to market.
What are you looking forward to at RegSmart?
I sincerely look forward to help expand RegSmart and the whole CTR group in to the MedTech and IVD field. The need for a competent organization that can guide innovative companies in the complex regulatory landscape is huge and has grown even larger after the transition from MDD/IVDD to MDR/IVDR. I am very excited to be part of a team and company group with extremely high competence and expertise in the area of clinical trials and regulatory strategies. We all have important roles to play in translating research into treatments that improves people’s health.
—–
”Welcome to RegSmart Mats! Your experience, knowledge and enthusiasm will be a great contribution to the RegSmart team! says Agneta Larhed, senior consultant and previous deputy Director, medical device at RegSmart”