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A warm welcome to our two new team members!

July 6, 2022
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We are glad to share with you that our Key2Compliance team has recently been joined by two new team members – Erik and Susanna. We are excited to introduce you to these two talented additions to our team!


ERIK BOM, Medical Device QA/RA Consultant

What will be your role at Key2Compliance?
I will work as a QA/RA consultant in the QA medical device team, where I will assist companies with quality management support, writing of IVDR / MDR technical documentation and other assignments related to medical devices.

What is your background?
I am originally from The Netherlands, and I have a M.Sc. degree in Pharmaceutical Sciences from the university in Amsterdam. I have been working for 6 years in compliance with ISO 9001, ISO 17025 and ISO 15189 within biomedical laboratories of the Dutch government. Since 2020 I have worked in compliance with ISO 13485 at a startup IVD company in Sweden. During this time, I worked as technical support lead as well as IT manager, and I was responsible for the development of a CE-IVD marked Medical Device software.

What are you looking forward to the most at Key2Compliance?
I am so happy to be joining such a fantastic team at Key2Compliance! I am looking forward to work with different types of customers and help them in their needs to get their innovative products through the required evaluation and regulatory processes.

 


SUSANNA HELLSTRÖM, Clinical Development Consultant

What will be your role at Key2Compliance?
I will work as a Clinical Development Consultant in the Clinical Investigations team with focus on project management and monitoring.

What is your background?
I am a pharmacist with 10 years of experience from Pharmacy work in Sweden where I have enjoyed helping customers and patients with their health. Previously I worked as a Study Coordinator in Australia for 5 years in late phase clinical studies investigating different Osteoporosis treatment. I have a MSc in Biomedicine and a BSc in Pharmacy from The University of Kalmar.

What are you looking forward to the most at Key2Compliance?
To interact with and support customers from different parts of Life Science and learn more about the world of Medical Device Development.  Although I have only been here a short while my fantastic colleagues at Key2Compliance have already taught me so much!

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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