Let us introduce our newest colleagues: Linda Hansson, Tatiana Mattsson and Susanne Grimsby! They are joining forces with us to help continue doing what we love to do: make complex things easier – all the way from idea to market.
LINDA HANSSON, Consultant Clinical Development
What will be your role at Key2Compliance?
I will be part of the clinical investigation team with focus on project management and monitoring.
What is your background?
Most recently I worked as a research coordinator/nurse within the field of psychiatry. Before that, I have spent +10 years working as a clinical research associate and been monitoring various project within oncology, diabetes, heart- and lung diseases and psychiatry. As a monitor, I have experience from the whole life cycle within a clinical investigation, from start-up to closure.
What are you looking forward to the most at Key2Compliance?
I am looking forward to help customers to get their various medical devices products approved for the benefits of the patients. I am also looking forward to work with all my talented colleagues at Key2Compliance. I will be part of a great team and I know I will learn a lot!
TATIANA MATTSSON, Medical writer Clinical Development
What will be your role at Key2Compliance?
Medical writer in the Clinical Development team.
What is your background?
I have a MSc in Molecular Biology and Biochemistry, and I defended my PhD thesis in 2006 at the Stockholm University on subject of Animal Physiology. I then continued as a postdoc at the Karolinska Institute, and most recently worked as a scientist at a private R&D company Anocca AB.
What are you looking forward to the most at Key2Compliance?
My employment at Key2Compliance will be my first ever try at working as a consultant. I am looking forward to learning new skills, learn about how the approval of medical devices work, how the regulations work. Looking forward to work with new projects and with different people within the Key2Comliance, and with our customers.
SUSANNE GRIMSBY, Senior Consultant Regulatory Affairs/Quality Assurance
What will be your role at Key2Compliance?
Consultancy service within regulatory affairs and quality assurance (QA/RA) for medical devices and IVD medical devices
What is your background?
I have more than 30 years of experience from the Life Science business of which the last 8 years in the medical device industry. After more than 20 years within research, I slipped into the QA/RA field by a coincident, but never regretted it. Although have learned a lot, there is always something new to learn.
I have had roles as QA/RA Manager both as employed and as consultant. My experience is mainly from small and mid-size medical device and IVD companies, where I have been working with various QA/RA activities, more or less everything that needs to be done to ensure quality and regulatory compliance. Examples of such are implementation and maintenance of quality management system (ISO 13485), product development, project management, risk management, change management and most of the parts in the CE-marking procedure. I have also experience from working with contract manufactures, including such as establishment of quality agreements and supplier audits. Beside this I also held trainings in the IVDR and love to share knowledge and experience.
What are you looking forward to the most at Key2Compliance?
I look forward to support Key2Compliance customers with whatever they need to make sure their products and organization meet current and future requirements on quality and regulatory compliance. A main part of this will of course be to support them with the implementation of MDR and IVDR. Since I have my background in a lab, I would very much like to support IVD´s and then especially the approaching challenges with the IVDR.
Lastly but not least, I really look forward to be a part of the strong and competent team at Key2Compliance, always eager to discuss and share whatever comes up.
Welcome to Key2Compliance! We wish you all the very best for your journey with us.
Interested in joining our talented and rapidly growing team of specialists? Check out our open opportunities here!
