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Welcome to the team!

September 13, 2022
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Welcome our newest rockstars to Key2Compliance, Heléne Lindegren, Malin Borg, Dalia Rhman och David Dahi. Four individuals who are joining us and no doubt will have a huge impact on their clients and teams! Welcome to the team!

 


HELÉNE LINDEGREN, Business & Contract Manager

What will be your role at Key2Compliance?
My role at Key2Compliance will be to handle customer relations in the clinical development team. I will also support with invoicing, timetracker, and admin processes.

What is your background?
I have worked as Key Account Manager for Merck Life Sciences AB before coming here. Worked as CFO and inside sales in a small company (Immunkemi AB). I have education in Chemistry from Stockholm University and a PhD in Neurochemistry & Neurotoxicology.

What are you looking forward to the most at Key2Compliance?
To learn about this very exciting medical device business and to get to know all my coworkers.


MALIN BORG, Senior Consultant Regulatory Affairs

What will be your role at Key2Compliance?
As a consultant, my primary focus is helping our clients navigating the regulatory landscape for medical devices in order to bring their products to market. I will also aid in risk management, quality assurance and everything related to software.

What is your background?
My background is in engineering physics and computer science. I started out working in pharma with Industry 4.0, IoT, smart factories and related areas but have gradually ventured more and more into medical devices. Before joining Key2Compliance I was Quality Assurance/Regulatory Affairs Manager at a software as a medical device startup company focusing on digital therapeutics.

What are you looking forward to the most at Key2Compliance?
I’m looking forwards to get new and innovative products that will change the lives of people from the innovational or design and development stages to market. For medical devices, all of the different aspects and components have to come together in order to produce the best product. In the same way, everyone at Key2Compliance works together so that we bring more to the table than just the skills and competences of each individual consultant, and this is what makes me so excited to be part of this company.


DALIA RHMAN , QA/RA Consultant

What will be your role at Key2Compliance?
Currently, my role is as a project manager helping medical device company with the new regulatory requirements. In the future, my role at Key2Compliance will include project management, Quality assurance and regulatory affairs.

What is your background?
I have master’s degree in Biomedicine. Previously, I worked in a similar role in a life science consulting company, and before that I gained a very valuable experience at a start-up company developing a new product on the market. As quality control and process responsible, I was able to follow the entire product design control processes until it was released to the US market. After completing my studies, I have gained very good experiences in genetic and rheumatological diseases, when I worked at the genetic clinic in Copenhagen and Lund.

What are you looking forward to the most at Key2Compliance?
I am looking forward to expanding my skills and becoming more of a specialist in my role. I also look forward to being able to collaborate with all professional Key2Compliance colleagues in internal and external projects.


DAVID DAHI, Quality Assurance / Regulatory Affairs Consultant

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

What is your background?
I am a scientist with a M.Sc. degree in Biomedical Methodology and Technology from Malmö University. Lately, I have been working as a Life Science consultant at Prevas providing QA/RA support to small and medium-sized medical technology companies that develops and sells software. Before that I have experienced to work as a production technician at Immunovia AB, focusing on developing tools for diagnosing diseases, in particular pancreatic cancer, using biomarkers. And before that I have worked in different roles in various hospital areas; mainly within Laboratory Medicine; Medical Laboratory Scientist at the Medical Microbiology and Medical Genetics (analyzed the DNA sequences), R&D (developed and validated laboratory processes for DNA-analyzes) and Quality Coordinator (ensured that routines and processes were followed up, secured and developed through quality in education and collaboration).

What are you looking forward to the most at Key2Compliance?
Key2Compliance’s first impression was great – genuine positive spirit and a high level of competence. Not only am I happy to be part of this great team and growing business, but I am also looking forward to a cross-functional collaborations, within my QA team and through the whole organization. My clear aim is to continue developing my expertise in QA/RA matters and supporting medical technology companies that develops software for medical use, worldwide.

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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