Marika E. Karjalainen Email & Phone Number

Helsinki, Fi

Helsinki, Uusimaa, Finland

Helsinki, Uusimaa, Finland

As a Regulatory Affairs Manager, my tasks include ensuring that the company complies with all relevantregulations and laws related to the medical device industry and company’s business field of software as a medical device. I manage communications and relationships between the company and relevant regulatory authorities in our market areas, and work closely with Aiforian teams to facilitate product development, approval, market entries, and monitoring.

Helsinki, Southern Finland, Finland

Helsinki Area, Finland

My main objective at the moment is to ensure that our IVD-products are compliant with the new (EU) 2017/746 regulation. This work includes establishing new processes and updating existing ones from the R&D point of view, and ensuring the safety and the satisfaction of our customers. As regulations and compliance are in a close relation with quality management, I find myself quite often from the depths of our quality system. Sometimes the tasks at hand require collaboration with clinical partners or marketing professionals. This versatility keeps my work days interesting, and offers something new to learn every day.

Espoo, Finland

I started as a research scientist at VTT in a project that aims to develop new applications for lignin, and in another that utilizes enzymes in cellulose modification. Lastly I was employed by a team that is focused on genetically engineering microbes in order to create recombinant protein producers for customer projects.

Espoo, Finland

The main objective of my thesis work was to develop a method for characterizing an in-house produced LPMO-enzyme, TrAA9A, and to analyze how this enzyme functions in different conditions. The method aimed to be a scaled down-version in order to save reagents and labor. Despite all kinds of troubles, the optimization was successful and I was able to conduct a minor characterization set for the enzyme. The thesis was submitted and accepted in October 2017.

Espoo

I was asked to join Orion Diagnostica's R&D-team right before the lab was moving to new facilities, and the development stage of their latest product required an update for the laboratory facilities and instructions. As a coordinator I was responsible for the organizing and moving to the new lab, composing instructions and updating methods. I was also given the tasks of familiarization, organizing supporting activities and coordination between different operations once the product development was ready for scale up. As a research assistant I designed, conducted and reported experiments for the development of a novel diagnostic tool. I also took part in productisation upscaling procedures, including freeze-drying optimization, and carried out quality control for the analyses.

Helsinki

As a member of the siRNA-technology services-team, I designed, conducted and reported customer based and in-house projects, mainly involving microarray printing and high content imaging. I was also borrowed to Drug Sensitivity and Resistance- team, where I was doing experiments with the help of Labcyte Access and BeckmanCoulter integrated robotic systems. I also took up the tasks to improve environmental issues as well as optimizing space use.

Vantaa

For a short period of time I was able to work with the remains of a great Finnish biotech company, Finnzymes, at the newly established facilities provided by the new technology owner, Thermo Fisher Scientific. As a member of Biochemical Products-group I designed, conducted and reported experiments during the development of RT-PCR-based products. Basic laboratory upkeep, budgeting and development were also my tasks. The fun ended to a shutdown of the whole department.

Helsinki

As a technician for a 20-people multinational research group at the Faculty of Biosciences, I was responsible for all the practicals in the laboratory. I handled samples from laboratory and field experiments from sampling to storing. My main task was developing and conducting techniques to research DNA and RNA from different types of samples, which could vary from ancient bones to whole frogs. I wrote my part of the research for the scientific publications and presented regularly the outcomes of my own projects. I took care of the familiarization of new employees and supervised students. As the unofficial "leisure and party planner" I organized several gatherings, parties and happenings for EGRU.

Mobidiag was founded in 2000, and since then they have established several product lines for molecular diagnostics of infectious diseases and antimicrobial resistances. At the early stages of the product development, my responsibilities were designing, conducting and reporting microbiological and molecular biological experiments. The company collaborated with several instances to collect clinical samples which needed to be stored and filed according to strict standards. This was also my task, as well as introduction of the quality system and all the paper work that followed. I was a member of the occupational safety team, and organising parties and leisure happenings fell upon me naturally.

Master'S Degree, Biochemistry

Major in protein science and biotechnology, minor in bioprocesses.

Basic Studies, Environmental Science

Basic Studies, Microbiology, General

Biomedical Laboratory Scientist, Molecular Biology And Genetics

Master'S Degree, Biochemistry

Major in protein science and biotechnology, minor in environmental engineering.