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Welcome to Our Newest Team Members!

February 4, 2022
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2022 brings exciting new opportunities to Key2Compliance, and with those we are happy to welcome no less than four new colleagues to our rapidly growing team. We are excited to introduce them to you, so please welcome Sandra Sernbo, Emily Malmberg, Winta Woldai and Nhung Södergren!

SANDRA SERNBO
SANDRA SERNBO, Consultant Clinical Development

What will be your role at Key2Compliance?
My role at Key2Compliance will be to do clinical evaluations.

What is your background?
Most recently I have been working as a consultant at Prevas performing clinical evaluations and performance evaluations. Before that I did a PhD at LTH in Lund and a Postdoc at the Pasteur Institute in Montevideo, both about biomarkers in cancer. I also have a Civil Engineering degree in Biotechnology from LTH.

What are you looking forward to the most at Key2Compliance?
I look forward to having a lot of skillful colleagues to collaborate with and to develop as a consultant within my expertise. I also look forward getting to know all colleagues when we are able to meet IRL again!

 

Emily Malmberg
EMILY MALMBERG, Consultant Clinical Development

What will be your role at Key2Compliance?
With the new regulations for Medical Technology, the MDR and IVDR, there is a higher requirement to present clinical data för your device. Simplified, I will help companies to perform clinical evaluations so that they can comply with the new regulations.

What is your background?
I have a PhD in Biomedicine and was a research scientist for many years, in Gothenburg, Scottsdale, AZ, USA and in Copenhagen. Then I worked for four years as Clinical Affairs Specialist at an IVD company for digital cell morphology here in Lund, CellaVision.

What are you looking forward to the most at Key2Compliance?
I am looking forward to meeting the costumers and to learn about all the different smart and creative products they manufacture to help patients. I am also looking forward getting to know all my new colleagues at our different sites in Sweden.

 

WINTA WOLDAI
WINTA WOLDAI, QA/RA Consultant

What will be your role at Key2Compliance?
I have a duo role at Key2Compliance, both as a QA/RA consultant in the QA medical device team and as a toxicologist in the biological evaluation and toxicology team.

What is your background?
I’m a toxicologist with experience in regulatory toxicology and QA. Before Key2Compliance I have worked as a QA/RA specialist in a pharmacy chain and life science consultant within medical device.

What are you looking forward to the most at Key2Compliance?
I’m looking forward to helping customers with complicated tasks and solving problems. I hope to evolve professionally and to be an asset to this wonderful competent team here at Key2compliance.


NHUNG SÖDERGREN, QA/RA consultant

What will be your role at Key2Compliance?
My role will be to help customer with different quality and regulatory tasks.

What is your background?
I have degree in chemistry from Gothenburg University. Since 2015 I have worked with quality assurance in the medical device and pharmaceutical industry, where I was process owner for GMP training/staff education, product release and deviations. I have also experience of different kind of eQMS system and working with product care, internal auditing, customer audits, complaints etc. Before this I have many years hands-on experience in production and quality control department.

What are you looking forward to the most at Key2Compliance?
I look forward to using my previous work experience and academic merit to help customer with different quality and regulatory tasks.

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!

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