Experience

Biohit Oyj

• Finland
• Biotechnology Research
• 1 - 100 Employee

• Junior Quality Specialist

  • Jan 2023 - Present

  The tasks are related to product compliance in accordance with MD and IVD regulations. I maintain the company's post-marketing surveillance system and I am developing an electronic quality management system for the company. In addition, I create various documentation templates (e.g. documents related to clinical and performance evaluation and clinical research) and actively do registrations for different countries.

• Quality and RD Assistant

  • Jun 2022 - Jan 2023

  Various tasks related to demonstrating product compliance according to IVD and MD regulations. In addition, the job description included tasks related to the quality management system and product development. Furthermore, I clarified the official requirements of non-EU countries (e.g. The United Kingdom & Switzerland).

• Quality and RD Trainee

  • Feb 2022 - Jun 2022

  The tasks were related to the implementation of requirements of the MD and IVD regulations (2017/745, 2017/746). In addition, I completed various tasks related to the quality management system and product development. For example, I created a post-marketing control system where the information, e.g. customer complaints, feedback, deviations are collected and analyzed.



Medfiles

• Finland
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Medical Device/IVD Assistant

  • Mar 2021 - Jun 2022

  Along with my studies, I worked as an hourly worker at Medfiles Oyj in the company's medical devices team. My job description included, for example, working in customer projects with performance demonstration of IVD tests and related literature reviews. I especially worked on demonstrating scientific validity related to diagnostic tests by planning e.g. literature searches from various databases (e.g. PubMed) and by analyzing literature and writing various reports. In addition, I searched the databases of the authorities of different countries/continents (Germany, UK, USA, Canada, Australia) for incidents related to diagnostic tests. Based on the search results, I wrote a report in which I summarized the search results and made conclusions about the safety of the test. During the spring of 2022, I wrote an extensive bachelor's thesis for the company, the topic of which was how to bring a medical device to the U.S. market through the 510(k) submission process. Through this thesis, the requirements related to the 510(k) process (and also other FDA application processes such as PMA & De Novo) became clear. The main purpose of the thesis was to provide information on the 510(k) pathway route to U.S. market and the relevant quality management system requirements for a manufacturer who would like to market their medical device in the U.S. medical device market. While working at Medfiles, I gained a broad and good understanding of the regulatory requirements related to medical devices (MD & IVD products) and how the functionality and safety of the products are monitored while they are on the market. Show less