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Welcome to Our Newest Team Members!

April 26, 2022
Happy on the beach

We are happy to announce that our team at Key2Compliance continues to grow steadily with another four new team members joining us. Please welcome Susanne El Makdisi, Oskar Öhman, Carmen Vogt and Christina Ehrenkrona on board!

 


SUSANNE EL MAKDISI, Medical Device QA Consultant

What will be your role at Key2Compliance?
My role will be to support medical device and IVD companies with their quality management and regulatory compliance.

What is your background?
Most recently, I have worked as a QA/RA consultant at an IVD company and assisting with improving and updating their QMS to be in compliance with the new IVDR as well as prepare for external audits by a notified body.

What are you looking forward to the most at Key2Compliance?
I’m looking forward to helping our customers reach their goals and to play a small part in bringing high quality, safe and innovative medical device and IVD products to market.

Of course, I’m also especially looking forward to cooperating with the highly experienced colleagues at Key2Compliance!


OSKAR ÖHMAN, Clinical Development Consultant

What will be your role at Key2Compliance?
I will work in the Biometrics-team with Data Management and Statistics activities.

What is your background?
I graduated from KTH in 2018 (MSc in Medical Biotechnology) and started my first job at Oncopeptides, a cancer research company focused on Multiple Myeloma.

I worked at Oncopeptides for almost 4 years where I had several roles working as a Clinical Data Analyst, Clinical Data Manager, and latest Clinical Data Scientist. The short version of it is that I started out working mainly with data analysis supporting Clinical project teams, R&D and Medical Affairs; then I worked mainly as Clinical Data Manager i.e., sort of project leader for data related activities, in delegated clinical studies and lastly, I had a mixed role and with additional responsibilities in Data Standards and more advanced data analysis.

What are you looking forward to the most at Key2Compliance?
To build up the most brilliant Biometrics unit in Sweden together with my teammates in the Clinical Development team.


CARMEN VOGT, Consultant Clinical Development

What will be your role at Key2Compliance?
I will work as a consultant and medical writer in the Clinical Development Team. Initially I will write Clinical Evaluation Plans and Reports.

What is your background?
I have a PhL in Materials Science (KTH) and a PhD in Toxicology from KI. I have worked many years with different aspects of developing nanoparticle-based contrast agents for imaging: synthesis, physical and chemical testing, cell and animal investigations.

What are you looking forward to the most at Key2Compliance?
I look forward to contributing to the core values of the company of helping clients to bring safe products on the market. I am also excited to get to know and be inspired by my colleagues in my long-life learning journey.


CHRISTINA EHRENKRONA, Senior Consultant Clinical Development

What will be your role at Key2Compliance?
My role at Key2Compliance is to support with overall clinical development of medical devices with focus on statistical activities in clinical trials such as writing statistical analysis plan and producing Tables, Figures and Listings including statistical analyses amongst others.

What is your background?
I have a background from the pharmaceutical industry and over 10 years’ experience within biostatistics including clinical trials across various therapeutical areas and phases.

What are you looking forward to the most at Key2Compliance?
I am looking forward to work with all these talented coworkers and to develop the statistical processes in order to assist our clients in the best possible way.

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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