Say hello to our newest colleagues: Claudia Dannehl, Maria de Matos and Afifa Trad! They are joining us to help continue doing what we love to do: make complex things easier – all the way from idea to market.
What will be your role at GBA Key2Compliance?
I will join Key2Compliance as a Senior Regulatory Affairs Consultant for medical devices – the first colleague in Germany!
What is your background?
I studied Physics and hold a phD in Biophysics. After my time in academia, I joined two medical device start up companies where I learned about the pain, but also the opportunities when building a QMS from scratch and writing a technical file for the very first time. Before joining Key2Compliance, I worked as a consultant in a comparable role in another Scandinavian company.
What are you looking forward to the most at GBA Key2Compliance?
I really look forward to the integration into a network of outstanding experts. Some of my previous customers had worked with Key2Compliance and I was impressed about the quality of their delivered work. And of course I am excited about the integration of Key2Compliance into the German GBA group.
What will be your role at GBA Key2Compliance?
As Clinical Development consultant, I will support our customers in the medical device and in vitro diagnostics industries with clinical and performance evaluations, and review and gap analysis of relevant parts of their technical documentation, in compliance with current regulations and standards. I will also help with interactions with Notified Bodies as needed and contribute to the strategy for the costumers’ clinical development.
What is your background?
I am a Biomedical Engineer, with a major in medical instrumentation and biomaterials, hold a PhD in Pharmaceutical Technologies, and was a research scientist for over a decade.
Prior to Key2Compliance, I worked as Clinical Evidence Evaluator for several years. Here, I not only worked with clinical evaluations and adjacent topics, but also gained experience in clinical evidence generation strategy and QA activities such as deviations, non-conformities and CAPAs.
What are you looking forward to the most at GBA Key2Compliance?
I am looking forward to helping businesses of all sizes and from different areas of the medical device/IVD industry with their challenging projects, while ensuring safety and performance of the devices and compliance to applicable regulations and standards.
I am also excited to collaborate with my very talented and competent colleagues from all business areas, build strong relationships with our customers, and contribute to the development and success of our company.
AFIFA TRAD, Business Development Consultant
What will be your role at GBA Key2Compliance?
I will be working in a dual role as a part-time Consultant and part-time Business Development Manager. In my consulting role, I’ll be using my broad experiences and insights from project management and Quality Management in the life science industry to help our clients, which are quite diverse. On the business development side, I’ll be supporting the team’s growth and forging new partnerships to expand our reach and impact.
What is your background?
I am a licensed pharmacist and therefor have a strong foundation in pharmaceutical sciences. Additionally, I will soon hold an MBA, which has equipped me with strategic and operational skills to complement my technical expertise. Over the years, I have been able to combine this technical expertise with roles contributing to organizational development, allowing me to understand both the scientific and commercial aspects of our industry. This is what I hope to be able accelerate at Key2Compliance.
What are you looking forward to the most at GBA Key2Compliance?
What excites me the most about joining Key2Compliance is the opportunity to merge my passions for process quality, operational excellence and business development. I’m really eager to collaborate with and learn from our competent team that has the ability to be a full-service provider and also explore how we as an organization might leverage being part of the larger GBA group. I look forward to engaging with our clients, understanding their unique needs as well as being enthusiastic about contributing to our business development efforts, identifying new opportunities, and fostering relationships that will push Key2Compliance forward.
Interested in joining our talented and rapidly growing team of specialists? Check out our open opportunities here!
