Our team keeps growing and we are delighted to welcome five new employees to Key2Compliance! We are happy to present to you Gustav Sundström, Joanna Jackson, Marika Lundin, Gunilla Zetterholm and Malin Truvé. They are all a fantastic addition to our team of senior specialists.
What will be your role at Key2Compliance?
I will be part of the Regulatory Affairs team, working mainly with technical documentation for MDR 2017/745.
What is your background?
I have a M.Sc. degree in aeronautical engineering but have been working at Intertek Semko AB for almost 15 years with electrical safety testing of medical equipment and laboratory equipment according to the 60601- and 61010-series. At Intertek I also worked as a technical file assessor for the Notified Body and did inspections of installed medical equipment such as X-ray systems and MR equipment at hospitals.
What are you looking forward to the most at Key2Compliance?
My previous work was focused on examining and testing equipment to find any deviations against the requirements of a standard. It was then up to the client to figure out a solution. Now I will be able to actually suggest solutions to the client and actually help them to comply to the regulatory requirements.
What will be your role at Key2Compliance?
As a member of the Regular Affairs team I will provide support to our clients in the medical device industry.
What is your background?
I have a worked for over 15 years in the medical device industry of which 7 in regulatory affairs. Prior to that I worked within Quality with process development, IT system implementations and document management. Most recently in regulatory my focus was on worldwide registrations supporting countries such as Brazil, Japan and Saudi Arabia.
What are you looking forward to the most at Key2Compliance?
I am already enjoying meeting clients and learning about their exciting products and look forward to more of that. Getting to know all of my new colleagues better is something I am also looking forward to.
What will be your role at Key2Compliance?
To help and support clients in the pharma industry with quality related tasks including training/education of staff.
What is your background?
I have a scientist background (phD in Virology) but have also worked in different roles in different industry segments; Biotech (project manager, product owner, field scientist), IT (sales, business developer) and of course Pharma where I have worked as consultant, focusing mostly on qualification, validation, product process, aseptic assurance, and training.
What are you looking forward to the most at Key2Compliance?
Having been part of Key2Compliance only for a few days I am already impressed by the high level of competence and vast number of exiting ideas for the future that are simmering in the company. I’m looking forward both to help drive ideas forward and to contribute to any interesting client assignments waiting ahead.
What will be your role at Key2Compliance?
I will be working as Training coordinator, In-house courses while Felicia Kehr is on maternity leave.
What is your background?
I have a long history in SAS where I worked in various departments, mainly within business and product development departments. I like to work in a team, and I get energy when working with people. I believe in the saying that 1+1=3.
What are you looking forward to the most at Key2Compliance?
To have the opportunity to work and develop in a new industry in a company that have high ambitions and competence in the life science area.
What will be your role at Key2Compliance?
I will be part of the Regulatory Affairs team, supporting clients to make sure that regulatory requirements are fulfilled. I will assist with, for example, risk management, usability, CE markings, qualifications and classifications of products according to MDR and QSR.
What is your background?
I have worked at Intertek Semko AB for the past four years, performing evaluations of medical devices used in hospitals, specialized clinics and other healthcare settings. I have performed electrical safety testing and process review towards several standards such as ISO 14971, IEC 60601-1, IEC 60601-1-6 and IEC 62366-1.
What are you looking forward to the most at Key2Compliance?
I look forward to helping our clients to put safe products on the market by fulfilling the regulatory requirements, deepen my knowledge and to get to know my amazing coworkers.
Interested in joining our talented and rapidly growing team of specialists? Check out our open opportunities here!
